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Respironics Novametrix, LLC

United States·US-MF-000007951

Last updated September 17, 2026

What Respironics Novametrix, LLC makes

Respironics Novametrix, LLC manufactures home continuous positive airway pressure (CPAP) units, including pre-hospital and adjustable pressure models, as well as disposable PEEP valves and nasal oxygen cannulas with carbon dioxide sampling capabilities. The company also produces electrical monitoring spirometers, pulmonary function testing accessories like mouthpieces and filters, and patient monitoring systems for carbon dioxide levels, including sidestream modules and cuvettes. Breathing circuit gas-sampling sets and standalone CO₂ monitoring devices are part of its portfolio.

The company’s devices are classified under FDA regulations as Class I, Class II, Class IIa, and Class IIb, with listings in the FDA’s 510(k) and UDI databases, as well as the EU’s eudamed registry. 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.

Information

Country: United States
Address: 3000, Minuteman Road, Andover, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Brenda Niel
EUDAMED SRN: US-MF-000007951
FDA FEI Number: 1219324
DUNS Number: —

Catalogue (174)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
PED/ADU Airway Adapter w Mouthpiece	6421-00	EUDAMEDFDA UDI	Class IIa	Active
LoFlo SAMPLING LINE KIT	3474-00	EUDAMEDFDA UDI	Class I	Active
CapnoTrak CO2/O2 Nasal Cannula	1103413	EUDAMEDFDA UDI	Class IIa	Active
CO2/Flow Sensor Pediatric	9766-00	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL	3470PED-00	EUDAMEDFDA UDI	Class I	Active
Capnostat 5 Mainstream CO2 Sensor	1015928	EUDAMEDFDA UDI	Class IIb	Active
Capnostat 5 Mainstream CO2 Sensor	1149471	EUDAMEDFDA UDI	Class IIb	Active
LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL	3473INF-00	EUDAMEDFDA UDI	Class IIa	Active
Pediatric/Adult Airway Adapter	6063-00	EUDAMEDFDA UDI	Class IIa	Active
CO2/Flow Sensor Adult	9767-00	EUDAMEDFDA UDI	Class IIa	Active
CO2/Flow Sensor Neonatal	9765-00	EUDAMEDFDA UDI	Class IIa	Active
LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric	3473ADU-00	EUDAMEDFDA UDI	Class IIa	Active
Capnostat 5 Mainstream CO2 Sensor	1149321	EUDAMEDFDA UDI	Class IIb	Active
CapnoTrak CO2 Nasal Cannula	1103408	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL	3469INF-00	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling Cannula PEDIATRIC NASAL	3468PED-00	EUDAMEDFDA UDI	Class I	Active
CapnoTrak CO2/O2 Oral Nasal	1105135	EUDAMEDFDA UDI	Class IIa	Active
Neonatal/Pediatric Airway Adapter	1149958	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL	3468INF-00	EUDAMEDFDA UDI	Class I	Active
CapnoTrak CO2 Oral Nasal Cannula	1105098	EUDAMEDFDA UDI	Class IIa	Active
LoFlo Airway Adapter Kit INFANT/NEONATAL	1149490	EUDAMEDFDA UDI	Class IIa	Active
Adapter Adult Reusable Capnostat	1149456	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling O2 Delivery Cannula INFANT NEONATE NASAL	1149482	EUDAMEDFDA UDI	Class IIa	Active
LoFlo Sidestream CO2 Module	1149372	EUDAMEDFDA UDI	Class IIa	Active
LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL	1149492	EUDAMEDFDA UDI	Class IIa	Active
Pediatric/Adult Airway Adapter	1149944	EUDAMEDFDA UDI	Class IIa	Active
LoFlo Sidestream CO2 Module	1149431	EUDAMEDFDA UDI	Class IIa	Active
LoFlo Airway Adapter Kit INFANT/NEONATAL	3472INF-00	EUDAMEDFDA UDI	Class IIa	Active
CapnoTrak CO2 Sampling Extension Line	1105136	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL	1149379	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling Cannula ADULT NASAL	3468ADU-00	EUDAMEDFDA UDI	Class I	Active
Pediatric/Adult Airway Adapter	1149450	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL	1149480	EUDAMEDFDA UDI	Class IIa	Active
CapnoTrak O2 Delivery Extension Line	1105137	EUDAMEDFDA UDI	Class IIa	Active
Capnostat 5 Mainstream CO2 Sensor	1149342	EUDAMEDFDA UDI	Class IIb	Active
LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL	3471ADU-00	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling Cannula w/Dehumidification Tubing ADULT NASAL	3468ADH-00	EUDAMEDFDA UDI	Class I	Active
Neonatal/Pediatric Airway Adapter	1149453	EUDAMEDFDA UDI	Class IIa	Active
15mm Male/Female Adapter-Low Deadspace	8937-25	EUDAMEDFDA UDI	Class I	Active
LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL	1149483	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL	3469PED-00	EUDAMEDFDA UDI	Class IIa	Active
LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric	1149491	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL	1149488	EUDAMEDFDA UDI	Class IIa	Active
Neonatal Flow Sensor	6718-00	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling Cannula w/Dehumidification Tubing ADULT ORAL/NASAL	3470ADH-00	EUDAMEDFDA UDI	Class I	Active
Neonatal/Pediatric Airway Adapter	1149383	EUDAMEDFDA UDI	Class IIa	Active
Pediatric/Adult Airway Adapter	7007-01	EUDAMEDFDA UDI	Class IIa	Active
CapnoTrak CO2/O2 Nasal Cannula	1103411	EUDAMEDFDA UDI	Class IIa	Active
Neonatal/Pediatric Airway Adapter	1149448	EUDAMEDFDA UDI	Class IIa	Active
Capnostat 5 Mainstream CO2 Sensor	1149368	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

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

Respironics Novametrix, LLC has six FDA recall records initiated between September 2, 2002, and July 29, 2011, all of which are marked as terminated. The recalls involve issues with audible alarms failing to activate under specific alert conditions, pressure lines potentially becoming occluded and displaying incorrect tidal volumes, and software errors causing two respiratory parameters (MValv and Vt/kg) to be inaccurately represented as higher than actual.

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
Jul 29, 2011	Z-3288-2011	—	terminated	Pressure lines maybe occluded and display incorrect tidal volumes.
Jul 29, 2011	Z-3287-2011	—	terminated	Pressure lines maybe occluded and display incorrect tidal volumes.
Jan 4, 2011	Z-2168-2011	—	terminated	Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual.
Jan 4, 2011	Z-2167-2011	—	terminated	Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual.
Aug 11, 2006	Z-1535-06	—	terminated	Audible alarm may not sound during an alert condition
Sep 2, 2002	Z-1049-04	—	terminated	Audio alarm may fail to sound when SpO2 limits drop below the set limits