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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 2 of 4

Device	Model / Reference	Registries	Class	Status
Airway Adapters	1149948	FDA UDI	Class I	Active
Capnostat 5	1154770	FDA UDI	Class II	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
LoFlo	1149494	FDA UDI	Class II	Active
WhisperPak 7.5cmH2O CPAP Ribbed, Med, 10	00	FDA UDI	Class II	Active
Flow Sensor	1149903	FDA UDI	Class I	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
Flow Sensor	1149905	FDA UDI	Class I	Active
NM3 Monitor, Dutch	7900	FDA UDI	Class II	Active
NM3 Monitor, English, Rental	7900	FDA UDI	Class II	Active
WhisperPak 7.5cmH2O CPAP Gamida, Case 10	00	FDA UDI	Class II	Active
NM3 Monitor, German	7900	FDA UDI	Class II	Active
WhisperPak, 10cmH2O - 22mm CPAP, Case 10	00	FDA UDI	Class II	Active
WhisperPak, M520 V5 H033 T956, Case 10	00	FDA UDI	Class II	Active
WhisperPak, M520 V5 H113 T2m, Case 10	00	FDA UDI	Class II	Active
WhisperPak, M572 V7 T956 C142 C955, 10	00	FDA UDI	Class II	Active
Exchange CO2 Sensor, C3	00	FDA UDI	Class II	Active
Exchange CO2 Sensor, NICO C3	00	FDA UDI	Class II	Active
A A, SPU PED ADU, 1149381, Qty10	1149381	EUDAMEDFDA UDI	Class IIa	Active
15mm Male/Female Adapter	8935-25	EUDAMEDFDA UDI	Class I	Active
LoFlo CO2 Sampling O2 Delivery Cannula w/Dehumidification Tubing PEDIATRIC ORAL/NASAL	3471PEH-00	EUDAMEDFDA UDI	Class IIa	Active
Neonatal/Pediatric Airway Adapter	6312-00	EUDAMEDFDA UDI	Class IIa	Active
Pediatric/Adult Flow Sensor	6717-00	EUDAMEDFDA UDI	Class IIa	Active
Pediatric/Adult Airway Adapter	1149386	EUDAMEDFDA UDI	Class IIa	Active
ADU Airway Adapter, QTY: 1, Maquet	1149447	EUDAMEDFDA UDI	Class IIa	Active
Capnostat 5 Mainstream CO2 Sensor	1036698	EUDAMEDFDA UDI	Class IIb	Active
LoFlo CO2 Sampling Cannula w/Dehumidification Tubing PEDIATRIC NASAL	3468PEH-00	EUDAMEDFDA UDI	Class I	Active
CapnoTrak Airway Adapter Set	1103415	EUDAMEDFDA UDI	Class IIa	Active
CapnoTrak CO2/O2 Oral Nasal	1105100	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL	3471PED-00	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling Cannula w/Dehumidification Tubing INFANT/NEONATAL NASAL	3468INH-00	EUDAMEDFDA UDI	Class I	Active
LoFlo Sidestream CO2 Module	1069879	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling Cannula w/Dehumidification Tubing PEDIATRIC ORAL/NASAL	3470PEH-00	EUDAMEDFDA UDI	Class I	Active
CapnoTrak Water Filter Assembly	1103416	EUDAMEDFDA UDI	Class I	Active
Philips Nm3 Respiratory Monitor With Ventassist	K103578	FDA 510(k)	Class II	Active
Model 509m Pulse Oximeter, Model 509m	K032755	FDA 510(k)	Class II	Active
Loflo C5 Co2 Sensor	K053174	FDA 510(k)	Class II	Active
Modification To Nico With Mars, Model 7300	K041450	FDA 510(k)	Class II	Active
Mercury Vco2 Module With Capnostat 5	K080652	FDA 510(k)	Class II	Active
Philips Nm3 Monitor, Model 7900	K091459	FDA 510(k)	Class II	Active
Spot Check Pulse Oximeter, 512/513	K032949	FDA 510(k)	Class II	Active
Nico With Mars, Model 7300	K030886	FDA 510(k)	Class II	Active
Tidal Wave Sp Model 710/715 And 715	K032971	FDA 510(k)	Class II	Active
Mercury Vco2	K092217	FDA 510(k)	Class II	Active
LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL	3470ADU-00	EUDAMEDFDA UDI	Class I	Active
Neonatal/Pediatric Airway Adapter	1149339	EUDAMEDFDA UDI	Class IIa	Active
Sample Line-Female Luer Connector	3476-00	EUDAMEDFDA UDI	Class I	Active
LoFlo Sidestream CO2 Module	1050797	EUDAMEDFDA UDI	Class IIa	Active
Neo Airway Adapter, QTY: 1, Maquet	1149465	EUDAMEDFDA UDI	Class IIa	Active
LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL	3469ADU-00	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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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