Is this your brand? Sign in to claim ownership.

SunMed

United States·US-MF-000009164

Last updated September 18, 2026

About

Anesthesia and respiratory care products. Humidity Delivered Just Right Explore DuoTherm® Humidification System for personalized, accurate patient care Learn MoreSeven Days, One Simplified SolutionExplore NEW BALLARD™ 7Day Closed Suction System Learn MoreNew Distribution Partnership Now partnering with Asker Healthcare to better serve customers in the UK, France, and GermanyReady for Any Intubation Extensive endotracheal tube portfolio \[…\]

From the manufacturer's own website. Source

What SunMed makes

SunMed manufactures reusable and single-use laryngoscope blades and handles, endotracheal tubes, airway devices (oropharyngeal and nasopharyngeal), and an endotracheal tube holder. The company also produces a mechanical external stethoscope for clinical use.

The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. SunMed is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does SunMed manufacture?

SunMed specializes in anesthesia and respiratory care products. Their portfolio includes reusable and single-use laryngoscope blades and handles, endotracheal tubes (both basic and specialized), oropharyngeal and nasopharyngeal airways, an endotracheal tube holder, and a mechanical external stethoscope. These devices are designed for clinical use in procedures like intubation and patient monitoring.

Where is SunMed based, and what does that mean for their regulatory standing?

SunMed is based in the United States. As a U.S.-based manufacturer, their devices are subject to FDA regulations. The FDA classifies SunMed’s products as either Class I or Class II, which determines the level of regulatory oversight required. Class I devices generally pose minimal risk, while Class II devices require special controls to ensure safety and effectiveness.

Are SunMed’s devices listed in any regulatory databases, and why does that matter?

Yes, SunMed’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency in the supply chain. Listing in the UDI database is a requirement for many FDA-regulated devices, helping healthcare providers verify product authenticity and compliance.

How are SunMed’s devices classified by the FDA, and what does that classification mean?

SunMed’s devices are classified under the FDA’s Class I and Class II categories. Class I devices are typically low-risk items like reusable laryngoscope handles, which may only require general controls like good manufacturing practices. Class II devices, such as some endotracheal tubes or airways, require additional regulatory controls to mitigate moderate risks, such as performance standards or post-market surveillance.

What does it mean for SunMed’s devices to be listed in the FDA’s UDI database?

Inclusion in the FDA’s UDI database means SunMed’s devices carry a standardized identifier that includes details like the manufacturer’s name, device description, and lot number. This system improves patient safety by enabling better tracking of devices in clinical settings, reducing the risk of counterfeit or mislabeled products, and facilitating recalls if necessary. It also supports regulatory compliance and transparency.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 2710 Northridge Dr. NW, Suite A, Grand Rapids, United States
Website: [email protected]
LinkedIn: linkedin.com/company/myairlife
Facebook: facebook.com/profile.php
Email: [email protected]
Phone: +1-269-873-0502
PRRC Contact: Robert Yamashita
EUDAMED SRN: US-MF-000009164
FDA FEI Number: —
DUNS Number: —

Catalogue (697)

Page 14 of 14

Device	Model / Reference	Registries	Class	Status
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 1.0	60105	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 0.5	60055	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 1.5	60155	EUDAMEDFDA UDI	Class IIa	Active
MYOTouch Muscle Stimulator	K233098	FDA 510(k)	Class II	Active
Cuffalert	K081805	FDA 510(k)	Class II	Active
Orthoplug Hard Bone Design	K955631	FDA 510(k)	Class II	Active
Sunmed Foley Catheters	K062112	FDA 510(k)	Class II	Active
Sunlite Laryngoscope	K921263	FDA 510(k)	Class I	Active
Easymed Peripheral Nerve Stimulator-Sunstin	K121743	FDA 510(k)	Class II	Active
Orthoplug Soft Bone Design	K955632	FDA 510(k)	Class II	Active
Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size 0.5	50055	EUDAMEDFDA UDI	Class IIa	Active
Vital Signs™ Pressure Infusor, 500 mL, Netted, 12/CS	N800012-CE	EUDAMEDFDA UDI	Class I	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 3.0	60305	EUDAMEDFDA UDI	Class IIa	Active
Vital Signs™ Pressure Infusor, 1000 mL, Netted, 12/CS	IN900012-CE	EUDAMEDFDA UDI	Class I	Active
Air-Q3 Exchanger, Size #00	10-1006	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation Size 0.0	30005	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Exchanger, Size #0	10-1005	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation Size 4.0	30405	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation Size 1.5	40155	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation Size 0.5	40055	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 0.0	60005	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation Size 5.0	40505	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size 4.0	50405	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation Size 0.5	30055	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size 3.0	50305	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation Size 2.0	40205	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size 0.0	50005	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation Size 0.0	40005	EUDAMEDFDA UDI	Class IIa	Active
Vital Signs Head Positioner	8000HDP-CE	EUDAMEDFDA UDI	Class I	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 2.0	60205	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size 2.0	50205	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Exchanger, Size #1	10-1004	EUDAMEDFDA UDI	Class IIa	Active
AirLife™ Volumetric Incentive Spirometer 2500ml	001904A-CE	EUDAMEDFDA UDI	Class I	Active
Air-Q3 Standard ILA with Manual Cuff Inflation Size 1.5	30155	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation Size 1.0	40105	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation Size 4.0	40405	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation Size 3.0	40305	EUDAMEDFDA UDI	Class IIa	Active
Vital Signs™ Pressure Infusor, 3000 mL, Netted, 12/CS	IN950012-CE	EUDAMEDFDA UDI	Class I	Active
Air-Q3 Standard ILA with Manual Cuff Inflation Size 2.0	30205	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation Size 5.0	30505	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 4.0	60405	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size 1.0	50105	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size 1.5	50155	EUDAMEDFDA UDI	Class IIa	Active
AirLife™ Volumetric Incentive Spirometer 4000ml	001902A-CE	EUDAMEDFDA UDI	Class I	Active
Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size 5.0	50505	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 5.0	60505	EUDAMEDFDA UDI	Class IIa	Active
Air-Q3 Standard ILA with Manual Cuff Inflation Size 1.0	30105	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

SunMed has 15 recall records initiated between April 27, 2007, and May 24, 2018, all of which are marked as terminated. The reasons cited include a breakage issue with acrylic bundles in the light tube of the MD Laryngoscope Blade GreenLine D Mac 3, potentially leaving a fragment in use, and a risk of the patient port retaining ring failing to seat securely, which could affect air delivery during use.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 24, 2018	Z-2157-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2152-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2156-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2149-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2154-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2151-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2155-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2150-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2153-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2145-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2146-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2147-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2158-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018	Z-2148-2018	—	terminated	There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Apr 27, 2007	Z-0459-2009	—	terminated	A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected. If breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth.