Clinical categories from the GMDN nomenclature, which classifies devices by what they are and what they do rather than by who makes them.
This category includes in vitro diagnostic kits designed to measure C-peptide levels in clinical specimens such as blood or serum. These kits use a chemiluminescent immunoassay method to detect C-peptide, which is a biomarker used to assess endogenous insulin production and help differentiate between type 1 and type 2 diabetes, evaluate insulin therapy, and investigate hypoglycemia.
C-reactive protein (CRP) IVD kits with precipitation/immunodiffusion are diagnostic tools used to detect CRP levels in clinical specimens, helping identify bacterial infections and inflammatory conditions. These kits contain reagents and materials that enable healthcare professionals to measure CRP accurately in patient samples.
CD207 cell marker IVD antibodies are used to detect the presence of CD207, also known as langerin, in clinical specimens. This detection can help in various clinical applications, such as diagnosing and monitoring diseases. These antibodies are designed to bind to specific antigenic determinants, allowing for qualitative and/or quantitative analysis.
CD22 cell marker IVDs are medical devices that use antibodies to detect the presence of CD22, a specific protein, in clinical specimens. These devices are used to help diagnose and monitor various conditions, including certain types of cancer. The antibodies in these devices bind to the CD22 protein, allowing for its detection and measurement. This information can be crucial in guiding treatment decisions and monitoring patient outcomes.
CD61 platelet glycoprotein IIIa marker IVD antibodies are used to detect specific markers in clinical specimens, helping in the diagnosis and study of various conditions. These antibodies are designed to bind to specific antigens, allowing for qualitative and quantitative detection of the CD61 marker. This is crucial in understanding platelet function and its role in health and disease.
This category includes single-use adhesive patches designed to hold medical cables, leads, or sensors in place on a patient’s skin during procedures. These patches are non-conductive, meaning they do not transmit electricity or interfere with the function of the attached device, and are made from synthetic polymer materials to ensure skin adhesion without causing irritation.
A cardiopulmonary bypass system blood gas sensor is a sterile transducer designed to measure the partial pressure of gases, such as oxygen and carbon dioxide, in the blood during cardiopulmonary bypass procedures. It is used clinically to monitor blood gas levels in real time, helping clinicians manage patient physiology during cardiac surgery.
Cardiopulmonary bypass system roller pumps are medical devices that circulate blood outside the body during heart-lung procedures, enabling gas exchange and reinfusion through a roller mechanism. They are essential components of cardiopulmonary bypass systems used in cardiac surgeries.
A cardiothoracic surgical procedure kit is a collection of sterile instruments, dressings, and materials used to assist with various cardiothoracic surgical procedures. These kits are designed to provide the necessary tools for surgeons to perform a range of operations, but are not specific to a single type of procedure. They do not contain any pharmaceuticals, making them non-medicated kits.
This category includes in vitro diagnostic (IVD) kits designed to detect cotinine, a metabolite of nicotine, in clinical specimens such as blood, saliva, or urine. These kits use an enzyme immunoassay (EIA) method to qualitatively or quantitatively measure cotinine levels, which helps assess tobacco use or exposure in clinical and research settings.
This category includes diagnostic test kits designed to detect cytomegalovirus (CMV) genetic material in patient samples using nucleic acid amplification techniques. These kits are used clinically to support the diagnosis and monitoring of CMV infection, particularly in immunocompromised individuals such as transplant recipients or neonates.
Dehydroepiandrosterone sulfate (DHEAS) IVD kits with chemiluminescent immunoassay are laboratory test systems designed to measure DHEAS levels in clinical specimens such as blood or serum. These tests help assess adrenal gland function and diagnose conditions related to hormone imbalances.
This category includes devices used to evaluate the performance of diagnostic x-ray equipment as part of routine quality assurance procedures. These instruments measure and record key x-ray parameters such as kilovoltage peak (kVp), milliampere-seconds (mAs), radiation dose, or exposure time to ensure imaging systems operate within acceptable limits for patient safety and image quality.
Ear microsystem seed/pellet devices are small, single-use items applied to the external ear surface to stimulate specific points for therapeutic purposes. They are used in auriculotherapy to help alleviate various health conditions by applying continuous pressure to meridian points.
An electrocardiograph for home use is a device that allows individuals to monitor their heart's electrical activity in the comfort of their own homes. This device is used to produce a graph of the heart's electrical activity, which can be useful in assessing cardiac physiology. The data collected can be used to help a physician diagnose and monitor various heart conditions.
An endoscopic electrosurgical submucosal lift/resection set is a collection of devices used during endoscopic mucosal resection to lift and remove abnormal tissue from the gastrointestinal tract. It typically includes a needle for injecting fluid beneath the mucosa to raise the lesion, an electrosurgical electrode such as a snare for cutting and coagulating the tissue, and may include accessories like dye spray catheters or suction caps to aid visualization and lesion elevation.
An endoscopic manual linear stapler is a handheld surgical instrument used to apply staples and join or fix soft tissues during various types of endoscopic surgery, including abdominal, gynaecological, and thoracic procedures. It is designed to approximate tissues, such as bowel ends, or secure a surgical mesh in place. The device is operated manually, using a mechanism like a trigger, to apply rows of staples to the targeted tissue.
This category includes in vitro diagnostic kits designed to detect immunoglobulin G (IgG) antibodies specific to Epstein-Barr virus (EBV) in patient specimens such as serum or plasma. These kits use an enzyme immunoassay (EIA) format to support the clinical assessment of EBV infection, which is associated with conditions like infectious mononucleosis and glandular fever.
An evacuated blood collection tube with K2EDTA is a sterile, single-use container made of glass or plastic that holds a pre-measured vacuum and the anticoagulant dipotassium EDTA. It is designed to collect, preserve, and transport whole blood samples for laboratory testing, including hematology, molecular diagnostics, and immunohaematology procedures such as blood typing and antibody screening.
An external ocular measurement camera is a handheld device used to capture digital images of the external parts of the eye, helping doctors diagnose eye problems like ptosis, strabismus, and glaucoma. It takes precise measurements of various eye features, such as pupil diameter and the distance between pupils. This information can be crucial in identifying and treating eye conditions. The device is designed for external eye examination only and does not capture images of the interior of the eye.
A faecal incontinence collector with catheterization is a single-use device designed to collect liquid or semi-liquid stool from patients who lack bowel control. It includes a collection bag, a rectal catheter for insertion, and connecting components, often made of soft plastic, and may feature a drainage port or syringe for emptying or administering medication.
A faecal-incontinence vaginal insert trial is a non-sterile, inflatable device designed to be inserted into the vagina to help manage bowel leakage associated with faecal incontinence. It works by inflating a balloon to gently press against the rectal wall, temporarily blocking stool passage to prevent incontinence, and can be deflated to allow normal bowel function when needed.
Fentanyl IVD, kit, enzyme immunoassay (EIA) devices are laboratory test kits designed to detect the presence of fentanyl in clinical specimens using enzyme immunoassay technology. These kits provide qualitative or quantitative results to help medical professionals identify fentanyl exposure in patients.
Flexible endoscopic stone-retrieval forceps, single-use are manual instruments designed to be passed through the working channel of a flexible endoscope to grasp and extract stones or foreign bodies from body lumens such as the urinary tract. They feature a flexible shaft with grasping claws at the tip that are opened and closed via a proximal handle, allowing clinicians to retrieve calculi or debris during minimally invasive procedures.
A foot-switch, pneumatic is a reusable pedal operated by compressed gas that allows a healthcare professional to control the activation or intensity of a connected medical device, such as a pneumatic surgical saw or wire driver, without using their hands. It is connected to the parent device via one or more hoses and relies on pressurized medical gas, such as medical air or nitrogen, to function.
A gastrointestinal telemetric monitoring system capsule is an ingestible, battery-powered electronic device that patients swallow to wirelessly transmit gastrointestinal parameters such as pH, pressure, temperature, or events like bleeding. These capsules contain sensors that send signals to an external receiver or transceiver, which displays the information or transmits it to a computer for analysis.
A general-purpose drying cabinet is an electrical device designed to warm and dry various items and medical products in a controlled environment. It features an insulated enclosure with shelves, heating elements, and temperature controls to ensure consistent drying conditions.
A haemodialysis conductivity standard solution is a salt-based liquid used to verify and adjust the accuracy of conductivity meters that measure the purity of dialysate and water used in haemodialysis treatments. It ensures that the dialysis fluid delivered to patients meets strict safety and performance standards by providing a known reference point for instrument calibration.
An electric height-adjustable toilet bracket is a wall-mounted fixture that uses an electric mechanism to raise or lower a toilet, allowing users with mobility impairments to customize the height for safer and more comfortable use. It is designed to support individuals with disabilities by enabling independent adjustment of toilet position to suit their physical needs.
Heparin anti-Xa IVD controls are materials used to check that laboratory tests for monitoring heparin therapy are working correctly. They help ensure the accuracy of assays that measure how well heparin inhibits factor Xa, a key part of the blood clotting process, in patient samples.
An instrument storage cabinet is a furniture-like device used in surgical and clinical settings to organize and store surgical instruments and related equipment. It is commonly found in operating rooms, procedure rooms, dental clinics, ophthalmology offices, and doctors' surgeries where instruments need to be kept clean, accessible, and protected.
Interferential electrical stimulation system electrodes are components that conduct electrical currents from a pulse generator to specific body areas, typically used for pain treatment. These devices work by using two conductors placed at opposite corners of a square, delivering interfering frequencies that create a beat frequency at their difference.
Intra-arterial needles are sterile, sharp, hollow metal instruments designed to puncture arteries for medical procedures. They may be heparinized to prevent blood clotting during use.
Intracranial and compartmental pressure monitors require accurate calibration to provide reliable readings. This category of device is used to generate a reference baseline for standardizing intracranial pressure and muscle compartment pressure readings, ensuring that the data collected is precise and trustworthy. These devices play a crucial role in clinical settings where monitoring pressure is vital for patient care. They facilitate the transfer of readings from a catheter to a pressure monitor, enabling healthcare professionals to make informed decisions.
An intrapartum pressure monitoring catheter is a flexible tube with a pressure sensor at its tip, designed to be inserted through the cervix during labor to measure uterine and amniotic cavity pressures. It is used clinically to assess the strength, timing, and pattern of contractions, helping healthcare providers evaluate labor progress and fetal well-being.
This category includes hand-held ultrasound probes designed to assess blood flow in vessels either by direct contact with an exposed vessel during surgery or by scanning the skin surface before or after a procedure. These devices use ultrasonic, Doppler, or transit time technology to detect flow and may also provide cross-sectional images of the vasculature.
Laparoscopic electrosurgical blunt dissectors are medical devices used to facilitate dissection between tissue planes during surgical procedures such as hernia repair, cholecystectomy, and colectomy. They are designed to be used through a laparoscopic instrument and can be connected to an electrosurgical diathermy generator to provide electrical current. These devices are typically long, rigid, and insulated, with a stainless steel tip that can be operated using ring handles. They are used to gently separate tissues, allowing for precise and minimally invasive surgery.
A laparoscopic multi-instrument access port, reusable is a medical device designed to create a pathway for multiple surgical instruments to enter the abdominal cavity through a single incision during minimally-invasive laparoscopic procedures. It helps maintain pneumoperitoneum and may include external instrument holding arms to facilitate surgical access.
This category includes reagents designed to detect nucleic acid from Legionella pneumophila bacteria in clinical samples. These substances are used as part of an in vitro diagnostic test to identify the presence of the pathogen, supporting diagnosis of Legionnaires' disease or Pontiac fever.
This category includes implantable devices made from synthetic polymers, such as polyester, designed to replace damaged or missing ligaments in the body. These devices are used to restore joint stability and function, commonly in knee or shoulder reconstructions where natural ligament tissue is insufficient or absent.
A lung spatula is a hand-held surgical instrument used to gently move or hold lung tissue aside during thoracic procedures, allowing surgeons better access to the operative site. It features a broad, blunt blade at the working end and an ergonomic handle, designed to avoid damaging delicate pulmonary surfaces while providing effective retraction.
This category includes reference materials used to calibrate in vitro diagnostic tests that detect methamphetamine in clinical samples. These calibrators provide known concentrations of methamphetamine to ensure accurate measurement in qualitative or quantitative assays.
A monitoring spirometer, electrical is a device that uses mains electricity to continuously measure a patient's tidal volume or minute volume to assess their breathing status. It can also evaluate the performance of resuscitation devices by measuring the volume and rate of gas delivered through their expiratory ports, and may include alarms for abnormal tidal volume levels.
This category includes in vitro diagnostic test kits designed to detect one or more antibodies linked to coeliac disease in patient samples. These kits use an enzyme immunoassay method to screen for markers such as anti-gliadin, anti-endomysial, anti-IgA, or anti-tissue transglutaminase antibodies, aiding in the clinical assessment of coeliac disease.
Multiple thyroid hormone uptake IVD kits are used to detect the levels of certain proteins in the blood that are associated with thyroid hormone uptake. These kits aid in the diagnosis of thyroid disorders, such as hypothyroidism or hyperthyroidism, by measuring the unbound portion of proteins like thyroxine binding globulin, transthyretin, and albumin in a clinical specimen. This is typically done using a chemiluminescent immunoassay method, which provides a quantitative and/or qualitative result.
A nasal lavage system is a device assembly used to irrigate and cleanse the nasal passages and sinuses by delivering a controlled flow of non-medicated liquid, such as saline solution. It is commonly used to relieve nasal congestion, manage allergy symptoms, and prepare or clean the nasal area before and after surgical procedures.
Neuron-specific enolase (NSE) IVD antibody devices are laboratory reagents designed to detect and measure levels of neuron-specific enolase in patient samples. These antibodies are used in clinical settings to help diagnose conditions related to neuronal damage or certain types of cancer.
This category consists of control materials used to verify the performance of in vitro diagnostic assays that detect nucleic acid hybridization, such as those used in fluorescent or chromogenic in situ hybridization (FISH/CISH) tests. These controls help ensure that the assay is functioning correctly by providing known positive or negative signals for the target nucleic acid sequences in a clinical specimen.
Nucleic acid sequencing reagent kits IVD are collections of reagents and materials designed for genetic analysis of clinical specimens on sequencing instruments. These kits typically include buffers, primers, enzymes, and deoxynucleotides that work together to enable accurate DNA sequencing for diagnostic purposes.
An orthodontic clasp made of metal wire is a custom-fabricated dental device designed to hold a removable orthodontic appliance in place by attaching to stationary teeth. It is shaped and adjusted chairside to fit the unique anatomy of an individual patient, providing retention and stability during orthodontic treatment.
An oximeter catheter, single-use is a flexible tube with a fiberoptic bundle at its tip that measures blood oxygen levels by analyzing light reflected or scattered from blood. It is used clinically to estimate oxygen concentration in the bloodstream, typically during critical care monitoring, and works in conjunction with an external oximeter device to provide real-time data.
Oxycodone IVD, kit, enzyme immunoassay (EIA) devices are laboratory test kits designed to detect the presence of oxycodone in patient samples using enzyme immunoassay technology. These tests help healthcare professionals monitor patient compliance with prescribed medications or identify potential drug misuse in clinical settings.
PCR/NAT negative control IVDs are materials or solutions designed to produce a negative result when used in nucleic acid amplification tests. They are used to verify assay performance, detect contamination, or identify non-specific amplification during qualitative or quantitative testing of clinical specimens.
A passive shoulder prosthesis is an artificial device designed to replace a missing shoulder joint as part of an external upper-limb prosthetic system. It does not contain active components or motors and relies on external forces, such as body movement or manual positioning, to achieve function and support limb alignment or appearance.
A peritoneal dialysis system is a medical device used to remove waste and excess fluids from the blood when the kidneys are no longer able to perform this function. This is achieved by infusing a special solution, called dialysate, into the abdominal cavity through a catheter and tubing system, allowing for the exchange of waste products from the blood to the dialysate. The system may include various components such as a pump, solution mixer, and monitor to control the dialysis process.
A phone or pager in this category is a telecommunication device designed to receive alerts from nurse call systems, home alert systems, or therapeutic equipment. It notifies caregivers, medical professionals, or nearby individuals when a patient requires urgent assistance, such as during a fall or when a button is pressed, and may also provide reminders during prolonged treatments like cryolipolysis.
Photometric/spectroscopic immunoassay analyzers are electrically-powered instruments that scan immunoassay reagent vehicles after exposure to clinical specimens to detect chemical substances and biological markers through photometry and light spectroscopy. These devices provide quantitative, semi-quantitative, and qualitative results for in vitro diagnostic measurements, often used for rapid testing at the point-of-care or in laboratory settings.
A plasma surgical system handpiece is a handheld instrument designed to work with a plasma surgical system control unit. It is used during open or laparoscopic surgery to coagulate, cut, or vaporize tissue by generating a stream of ionized argon gas (plasma) at its tip, which delivers thermal and kinetic energy to the target tissue upon contact.
Polymeric dental burs are rotary devices designed to be attached to slow speed dental handpieces for removing infected or decayed dentin while preserving healthy tissue. These specialized instruments are crafted from materials like glass-bead-reinforced polymer or polyetheretherketone (PEEK) that deform upon contact with harder, healthy dentin.
Potassium (K+) in vitro diagnostic (IVD) reagents are substances used in conjunction with other diagnostic devices to measure the level of potassium in a patient's specimen. These reagents play a crucial role in clinical settings, helping healthcare professionals diagnose and monitor various conditions related to potassium levels. The measurement of potassium is essential for assessing electrolyte balance and detecting potential disorders.
Procalcitonin (PCT) IVD controls are materials used to check that laboratory tests measuring procalcitonin levels in patient samples are working correctly. They help ensure the accuracy and reliability of assays used to support the diagnosis and monitoring of bacterial infections and sepsis.
Professional hair-removal electrolysis systems are medical devices designed to permanently remove unwanted body hair by using an electric current to destroy the hair root through a fine needle electrode inserted under the skin. These systems are typically used in clinical settings by trained professionals to provide long-term hair reduction solutions.
Protein electrophoresis IVD controls are materials used to check that a laboratory test for separating and measuring proteins in patient samples is working correctly. They help ensure the accuracy of results when assessing conditions such as liver disease, kidney disorders, or immune system abnormalities by confirming the test system performs as expected.
A proton therapy system is a specialized medical device assembly designed to produce and deliver precise proton beams for treating localized tumors and other radiation-sensitive conditions. These systems utilize components for beam generation, transportation, and delivery, along with patient positioning and control mechanisms tailored to specific clinical requirements.
This category includes reusable bipolar handpieces designed for use with radio-frequency skin contouring systems. These applicators deliver RF energy through capacitive coupling between two tips to generate deep heat in the skin, promoting tissue remodeling for non-invasive body contouring and skin tightening procedures.
A radiopaque non-woven surgical sponge is a single-use, absorbent pad made from materials like rayon or polyester that is used during surgery to manage fluids, control bleeding, or protect tissues. It is designed for internal use on incisions, organs, or body structures and includes an x-ray detectable marker to help prevent retained surgical items.
A reference electrode IVD is a component used in electrochemical testing systems to provide a stable and known electrical potential during the measurement of electrolytes in clinical samples such as blood or urine. It does not measure analytes itself but ensures the accuracy of the measurement by serving as a baseline for the sensor system.
A respiratory oxygen monitor, line-powered is a mains electricity (AC-powered) device used to continuously measure the concentration of oxygen in the gas a patient is breathing during respiratory therapy or anesthesia. It is commonly used in settings such as ventilator circuits, oxygen tents, or anesthesia machines to ensure delivered oxygen levels remain within safe and prescribed limits.
This category includes in vitro diagnostic test kits designed to detect immunoglobulin G (IgG) antibodies specific to SARS-CoV-2 in human clinical specimens. These kits use a chemiluminescent immunoassay method to qualitatively or quantitatively measure IgG antibodies, aiding in the assessment of prior exposure to or immune response against the virus that causes COVID-19.
This category includes control materials used to verify the performance of in vitro diagnostic assays that detect SARS-CoV-2 nucleic acid in clinical specimens. These controls are not diagnostic tests themselves but are used alongside them to ensure the assay is functioning correctly during testing runs.
SOXC protein IVD, antibody devices are laboratory tests that detect specific SOX proteins (SOX4, SOX11, SOX12) in patient samples using antibodies. These tests help identify the presence and quantity of these proteins, which are important for diagnosing certain medical conditions.
SSA/Ro antibody IVD kits are laboratory tests designed to detect anti-SSA or anti-Ro antibodies, also known as Sjogren's antibodies, in patient samples using enzyme immunoassay methods. These tests help clinicians diagnose autoimmune conditions like Sjogren's syndrome, lupus, and other rheumatic diseases by identifying specific antibodies in the blood.
This category includes in vitro diagnostic (IVD) kits designed to detect anti-SSB or anti-La antibodies, also known as Sjogren's antibodies, in patient specimens such as serum or plasma. These tests use an enzyme immunoassay (EIA) method to support the clinical assessment of autoimmune conditions, particularly Sjogren's syndrome, by identifying specific autoantibodies associated with the disease.
A skin abrasion unit is a mains-powered device designed to remove the outer layer of skin through mechanical abrasion, typically using a rotating tool such as a wire brush or emery disc. It is used clinically in dermatological and plastic surgery procedures to improve skin texture by treating scars, tattoos, pigmented lesions, fine wrinkles, and other superficial skin irregularities.
Skin semi-occlusive dressings are used to help heal and protect injured or diseased skin by creating a physical barrier that reduces moisture loss. They are applied topically to open wounds and skin conditions, such as lacerations, burns, and surgical wounds, to promote healing and prevent abnormal scar formation.
This category includes diagnostic test kits designed to detect antibodies against the Sm/RNP antigen complex in patient samples. These kits use an enzyme immunoassay method to support the clinical assessment of autoimmune conditions, particularly systemic lupus erythematosus and related disorders.
Spinal decompression cutting handpieces/endpieces are sterile, hand-held surgical instruments designed to remove soft and hard tissue from the spinal area to relieve pressure on nerves, particularly in cases of spinal stenosis or degenerative disk disease. These devices typically consist of a handpiece with a metal shaft that may have a straight or curved tip ending in a rotary cutting burr, powered by an electric or pneumatic motor.
Splint padding/strapping material is a flexible, multi-layered sheet designed to cushion and secure a splint against a limb, most commonly used in pediatric care to improve comfort and stability during immobilization. It is typically composed of cotton, nylon, and non-latex rubber such as neoprene, allowing it to be trimmed to fit specific anatomical needs while providing soft, breathable support.
Stationary electric high-frequency ventilators are AC-powered machines designed to assist or control alveolar ventilation by delivering breaths at a frequency much higher than normal breathing rates and with tidal volumes equal to or less than anatomic dead space. They are commonly used in critical care settings to support patients with respiratory failure, often through an artificial airway like an endotracheal tube or tracheostomy.
A stretcher all-terrain wheeled undercarriage is a non-powered, manually-operated device designed to transport patients in recumbent positions, particularly over challenging terrains that standard ambulances cannot access. It features a robust frame with large wheels and is intended to facilitate patient movement between emergency vehicles, shelters, and medical facilities in difficult environments.
Surgical tissue compression devices are used to flatten, compact, or sculpt tissues and materials before they are used in surgery. They are designed to prepare implantable tissues, such as bone or cartilage, for surgical procedures. These devices help to shape and compress the tissues to the desired form. This process is crucial in ensuring the success of the surgical procedure.
A thermal-dilution cardiac output unit is a medical device that measures how much blood the heart pumps per minute by using a temperature-based indicator dilution. It works by introducing a cold or temperature-changed solution into the bloodstream and detecting the resulting temperature changes downstream via a specialized catheter with a thermistor, allowing calculation of cardiac output.
Total human chorionic gonadotropin IVD controls are materials used to verify the performance of assays that detect total human chorionic gonadotropin in clinical specimens. These assays are used to qualitatively and/or quantitatively detect various forms of HCG, including intact and nicked HCG, as well as alpha and beta subunits. This is important for ensuring accurate test results in clinical settings.
This category includes test kits designed to measure the total amount of testosterone in a patient's blood, saliva, or other clinical sample. These kits use an enzyme immunoassay method to detect testosterone levels, which helps healthcare providers assess hormonal function related to reproduction, development, or endocrine disorders.
An ultrasound hyperthermia system transducer, extracorporeal is a component of a therapeutic ultrasound system designed to deliver focused sound waves that generate heat within targeted tissues. It is positioned outside the patient’s body and used to produce localized or systemic heating for therapeutic purposes, such as in oncology or pain management applications.
A urine flowmeter, single-use is a non-electrical device designed to measure the volume or flow rate of urine from a patient during normal urination or while catheterized. It may include a drip chamber to help prevent retrograde bacterial contamination of the bladder and is intended for one-time use only.
Vaginal mucosa protection dressings are topical substances such as gels, creams, or suppositories designed to support the health and integrity of the vaginal lining. They are used to soothe, lubricate, and promote healing of dry, irritated, atrophic, or injured vaginal tissue, and may also act as a barrier to reduce the adherence of harmful microorganisms, particularly fungi, to the vulvovaginal area.
This category includes electronic systems designed to assess how the eyes function by measuring electrical activity, visual perception, and eye movements. These devices help clinicians evaluate retinal function, neural pathways from the eye to the brain, and ocular motor control through tests such as electroretinography, visual evoked potentials, and eye tracking.
Wearable electric massagers are devices designed to provide therapeutic massage to larger areas of the body than hand-held massagers. They typically come in the form of wearable wraps with vibrating nodes that mechanically stimulate muscles or offer physiotherapy treatment, and may include heat therapy.
A whole-blood-recovery autotransfusion system, powered is a closed-circuit assembly designed to collect, filter, and reinfuse a patient’s own blood lost during or after surgery. It enables autologous blood transfusion by capturing shed blood from the surgical site, processing it through filtration components, and returning it to the patient via a transfusion set, reducing or eliminating the need for donor blood.
A wound drainage bag is a single-use plastic pouch designed to collect exudate, blood, or other bodily fluids from large wounds or fistulas. It adheres directly to the skin via an adhesive flange that can be trimmed to fit the wound perimeter, providing a secure seal and may offer some protection to the surrounding skin.
A wound irrigation cannula is a rigid or semi-rigid tube designed to connect to a parent device like a syringe, allowing irrigation fluids such as saline solution to be directed to skin or surgical wounds for cleaning and debris removal. These devices facilitate effective wound management by ensuring targeted fluid delivery without aspiration capabilities.
A 24-hour urine specimen container IVD, no additive is a single-use plastic receptacle designed to collect urine over a 24-hour period for laboratory analysis and diagnostic testing. These containers typically have a capacity of 2 to 4 liters and are used to preserve urine samples during transport to laboratories.
A 6-acetyl morphine IVD calibrator is a specialized substance used to set reference points for laboratory testing. These materials are essential for ensuring the accuracy of assays designed to detect or measure the presence of 6-acetyl morphine in clinical samples.
An allergy testing lancet is a sterile, single-use device designed to gently puncture the skin during allergy testing procedures. It features a sharp triangular tip that allows a healthcare professional to introduce a small amount of allergen extract into the epidermis to observe for allergic reactions.
An alternating-pressure chair cushion system consists of a specialized cushion paired with a dedicated control pump. These systems are used to periodically shift contact points between the user and the seat, which helps relieve pressure and prevent the development of skin ulcers in individuals with limited mobility.
An ampule opener is a specialized cutting instrument designed to safely remove or break the sterile seal of an ampule, protecting users from sharp edges during the process. These devices are commonly used in clinical settings to prepare medications stored in ampules for administration.
This category consists of diagnostic test kits designed to identify and measure antibodies targeting the cardiolipin-beta-2-glycoprotein I complex within a patient sample. Clinicians use these enzyme immunoassay tools to detect specific immune responses that may be associated with autoimmune conditions.
This category includes in vitro diagnostic (IVD) kits designed to measure the concentration of apolipoprotein A-I (Apo A1) in patient specimens such as blood serum or plasma. These kits use nephelometry or turbidimetry methods to quantify Apo A1, a major protein component of high-density lipoprotein (HDL), which is clinically useful in assessing cardiovascular disease risk and lipid metabolism disorders.
An artificial airway stylet is a rigid wire or rod inserted into the lumen of an endotracheal or bronchial tube to provide stiffness and maintain its shape during intubation. This facilitates the insertion of the tube into the trachea by improving maneuverability and control, and the stylet is removed once the tube is properly positioned.