Is this your brand? Sign in to claim ownership.

ORIDION MEDICAL 1987 LTD.

Last updated May 27, 2026

What ORIDION MEDICAL 1987 LTD. makes

Oridion Medical produces nasal oxygen cannulas with integrated carbon dioxide sampling, single-use respiratory tubing for gas monitoring, and portable carbon dioxide monitors. Their product line also includes rechargeable battery packs for mobile use, reusable electrical connection cables, and patient monitoring modules for continuous CO₂ tracking.

The company’s devices are classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) and UDI databases. The manufacturer 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 Oridion Medical 1987 Ltd. manufacture?

Oridion Medical 1987 Ltd. specializes in respiratory monitoring and oxygen delivery devices. Their product line includes nasal oxygen cannulas designed with carbon dioxide sampling capabilities, single-use respiratory tubing for gas monitoring, portable carbon dioxide monitors, rechargeable battery packs for mobile use, reusable electrical connection cables, and patient monitoring system modules for continuous CO₂ tracking. These devices are primarily focused on improving respiratory care and patient monitoring.

Where is Oridion Medical 1987 Ltd. based, and how does that affect its regulatory oversight?

Oridion Medical 1987 Ltd. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The FDA classifies their products as either Class I or Class II, depending on the risk level and intended use. This classification determines the regulatory pathway for authorization, such as the 510(k) premarket notification process for Class II devices, while Class I devices may have fewer regulatory hurdles but still require compliance with FDA guidelines.

Which regulatory databases list Oridion Medical’s devices, and why are these important?

Oridion Medical’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) database records premarket submissions for Class II devices to demonstrate substantial equivalence to existing authorized products, ensuring safety and effectiveness. The UDI system provides a standardized identification system for devices, improving traceability, tracking, and regulatory compliance throughout their lifecycle, which is critical for patient safety and supply chain management.

How are Oridion Medical’s devices classified under FDA regulations, and what does that mean for their use?

Oridion Medical’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls like good manufacturing practices, while Class II devices involve a higher level of risk and require additional premarket notifications (such as the 510(k)) to ensure their safety and performance. This classification helps healthcare providers and regulators understand the level of oversight and validation required for each device before clinical use.

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

Information

Country: US
Address: —
Website: covidien.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(508)261-8000
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 600111512

Catalogue (217)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Mac-Line Co2 Nasal Cannula Sample Line	K012391	FDA 510(k)	Class II	Active
Microstream Filterline Icu	K121927	FDA 510(k)	Class II	Active
Microstream Filterline Icu	K980327	FDA 510(k)	Class II	Active
Capnostream20p With Ai/Odi	K112368	FDA 510(k)	Class II	Active
Capnostream 35 Portable Respiratory Monitor	K200594	FDA 510(k)	Class II	Active
Oridion Mac-Line Oral Nasal Cannula Sample Line	K012394	FDA 510(k)	Class II	Active
Microstream Nasal Cannula Filterline	K980325	FDA 510(k)	Class II	Active
Microstream O2/Co2 Oral Nasal Filterline	K011536	FDA 510(k)	Class II	Active
Capnostream 35 Portable Respiratory Monitor	K150272	FDA 510(k)	Class II	Active
Microcap	K981114	FDA 510(k)	Class II	Active
Microstream External Battery Charger	K002163	FDA 510(k)	Class II	Active
O2/Co2 Nasal Filterline	K010024	FDA 510(k)	Class II	Active
Smart Capnoline Guardian	K093388	FDA 510(k)	Class II	Active
Capnostream20p With Hifi C02 Monitoring	K123690	FDA 510(k)	Class II	Active
Validation Of The Breathid System, For The Detection Of Helicbactor Pylori	K011668	FDA 510(k)	Class I	Active
Mac-Line 02/Co2 Nasal Cannula Sample Line	K012395	FDA 510(k)	Class II	Active
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line	K181467	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (29)

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

Date	Recall No.	Class	Status	Reason
Feb 16, 2012	Z-1333-2012	—	terminated	CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
Feb 16, 2012	Z-1334-2012	—	terminated	CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
Feb 16, 2012	Z-1332-2012	—	terminated	CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
Dec 1, 2011	Z-1347-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Dec 1, 2011	Z-1346-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Dec 1, 2011	Z-1350-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Dec 1, 2011	Z-1349-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Dec 1, 2011	Z-1348-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Mar 25, 2011	Z-2235-2011	—	terminated	fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
Mar 25, 2011	Z-2236-2011	—	terminated	fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
Mar 25, 2011	Z-2233-2011	—	terminated	fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
Mar 25, 2011	Z-2234-2011	—	terminated	fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
May 26, 2010	Z-2010-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2013-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2002-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2011-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2003-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2005-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2006-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2012-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2001-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2007-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-1999-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2004-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2014-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2008-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2009-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2000-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
Jun 30, 2009	Z-2232-2009	—	terminated	1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Oridion Medical 1987 Ltd. JERUSALEM · IL FEI 3001227743