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Respironics Novametrix, LLC

United States·US-MF-000007951

Last updated September 17, 2026

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 1 of 4

Device	Model / Reference	Registries	Class	Status
NM3 Monitor, Italian	7900	FDA UDI	Class II	Active
NM3 Monitor, English, Refurbished	7900	FDA UDI	Class II	Active
NM3, English, Demo Unit	7900	FDA UDI	Class II	Active
WhisperPak 5.0cmH2O CPAP Gamida, Case 10	00	FDA UDI	Class II	Active
Respironics Alice, LoFlo, C5 Sidestream Module Refurbished	00	FDA UDI	Class II	Active
WhisperPak, 7.5cmH2O CPAP Bari U Hosp 10	00	FDA UDI	Class II	Active
LoFlo Sidestream CO2 Module	1154769	FDA UDI	Class II	Active
WhisperPak, Pre-Hosp 5cmH2O CPAP Case 10	00	FDA UDI	Class II	Active
LoFlo	1149435	FDA UDI	Class II	Active
Criterion OxiCheck	00	FDA UDI	Class II	Active
WhisperPak, PerformaTrak, MED	00	FDA UDI	Class II	Active
Respironics	8751-00	FDA UDI	Class I	Active
LoFlo	1149474	FDA UDI	Class II	Active
LoFlo	1149478	FDA UDI	Class II	Active
WhisperPak 5.0cmH2O CPAP, Normed Case 10	00	FDA UDI	Class II	Active
Airway Adapters	1149468	FDA UDI	Class I	Active
LoFlo	1149495	FDA UDI	Class II	Active
WhisperPak, Pre-Hosp, 7.5cmH2O CPAP, 10	00	FDA UDI	Class II	Active
WhisperPak, M520 V10 H113 T2m, Case 10	00	FDA UDI	Class II	Active
NM3 Monitor, Spanish	7900	FDA UDI	Class II	Active
WhisperPak 10.0cmH2O CPAP Bari U Hosp 10	00	FDA UDI	Class II	Active
NM3 Monitor, French	7900	FDA UDI	Class II	Active
WhisperPak 5.0cmH2O - 22mm CPAP, Case 10	00	FDA UDI	Class II	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
WhisperPak, M520 V10 H033 T956, Case 10	00	FDA UDI	Class II	Active
WhisperPak, Face Mask, Case 10	00	FDA UDI	Class II	Active
LoFlo	1149484	FDA UDI	Class II	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
WhisperPak, M691 V10 T2m C500, Case 10	00	FDA UDI	Class II	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
NM3 Monitor, Swedish	7900	FDA UDI	Class II	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
WhisperPak, 5.0cm CPAP, Bari U Hosp, 10	00	FDA UDI	Class II	Active
WhisperPak, M572 V10 T956 C142 C955 Case 10	00	FDA UDI	Class II	Active
Whisperpak CPAP Valve	00	FDA UDI	Class II	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
WhisperPak, 7.5cmH2O - 22mm CPAP, Case 10	00	FDA UDI	Class II	Active
Capnostat CO2 Sensor	00	FDA UDI	Class II	Active
WhisperPak, M520 V7 H033 T956, Case 10	00	FDA UDI	Class II	Active
WhisperPak, M520 V7 H113 T2m, Case 10	00	FDA UDI	Class II	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
NM3 Monitor, English	7900	FDA UDI	Class II	Active
LoFlo	1149476	FDA UDI	Class II	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
WhisperPak, M520 H113 T2m, Case 10	00	FDA UDI	Class II	Active
Capnostat CO2 Sensor	00	FDA UDI	Class II	Active
NM3 Monitor, Portuguese	7900	FDA UDI	Class II	Active
Airway Adapters	1149942	FDA UDI	Class I	Active
Whisperflow CPAP Valve	00	FDA UDI	Class II	Active
WhisperPak, M572 V10 T987 C142 C955, 10	00	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

Importers

Not available yet.

Notified Bodies

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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.

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