Skip to content

DFB Flowmeter 0-15 LPM Thorpe

by Maxtec, Inc.

Ref R219P77-400

DFB Flowmeter 0-15 LPM Thorpe (R219P77-400) is a medical gas flowmeter (EU MDR Class IIa; FDA Class I; FDA product code BXY, Flowmeter, Calibration, Gas) made by Maxtec, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 081777002ACRYLICFMAE) and listed in FDA GUDID since 4 Dec 2020 (UDI-DI 00817770022459), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081777002ACRYLICFMAE Basic UDI-DI 00817770022459UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817770022459 UDI-DI Date4 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081777002ACRYLICFMAE registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00817770022459 listed 4 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817770022459
  2. Registered EUDAMED 081777002ACRYLICFMAE

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  • Withdrawn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
Flowmeter, 0–15 LPM, Standalone DFB, 60 PSI DISS Fitting EUDAMED
DFB Flowmeter GUDID
Generic name
Medical gas flowmeter, Thorpe tube
Device name
Acrylic Flowmeter
Model / Ref / Catalog
R219P77-400, 0-15 LPM Thorpe
Primary DI / UDI-DI
00817770022459
Basic UDI-DI
081777002ACRYLICFMAE
Direct marketing DI
00817770022459
FDA product code
BXY
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Medical gas flowmeter, Thorpe tube
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.2350
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
R219P77-400
GUDID
0-15 LPM Thorpe
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.

Related devices

Category: Medical gas flowmeter, Thorpe tube

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)