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Neonatal Flow Sensor

by Respironics Novametrix, LLC

Part of a family of 10 devices: see the family page

Ref 6718-00

Neonatal Flow Sensor (6718-00) is a breathing circuit gas-sampling/monitoring set (EU MDR Class IIa; FDA Class I; FDA product code BXP, Transducer, Gas Flow) made by Respironics Novametrix, LLC, registered in EUDAMED on 15 Oct 2024 (Basic UDI-DI 0884838BM626TA) and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 00884838014152), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM626TA Basic UDI-DI 00884838014152UDI-DIDate15 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838014152 UDI-DI Date14 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM626TA registered 15 Oct 2024 Active
  • FDA GUDID UDI-DI 00884838014152 listed 14 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884838014152
  2. Registered EUDAMED 0884838BM626TA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Neonatal Flow Sensor EUDAMED
Flow Sensor GUDID
Generic name
Breathing circuit gas-sampling/monitoring set
Model / Ref / Catalog
6718-00
Primary DI / UDI-DI
00884838014152
Basic UDI-DI
0884838BM626TA
FDA product code
BXP
EMDN code
Z12150185 Spirometry instruments - consumables
GMDN term
Breathing circuit gas-sampling/monitoring set
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.2885
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000007951
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Related devices

Category: Pulmonary function testing filter/mouthpiece

Similar devices in this category

Other devices filed under SPIROMETRY INSTRUMENTS - CONSUMABLES.

Other devices from Respironics Novametrix, LLC

See all devices from Respironics Novametrix, LLC →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)