Skip to content

Infant Flow LP System

by ZOLL Medical Corporation 7 variants

Part of a family of 6 devices: see the family page

Ref 777040M-40

Infant Flow LP System (777040M-40) is a device classified as Class I in the EU and Class II in the US made by Zoll Medical Corporation, registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 08479460BTCL), cleared under FDA 510(k) K050994 on 3 Aug 2005 and listed in FDA GUDID since 24 Jun 2026 (UDI-DI 00198843003576), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K050994

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08479460BTCL Basic UDI-DI 00198843003576UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00198843003576 UDI-DI Date24 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK050994 Date3 Aug 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08479460BTCL registered 9 Jul 2026 Active
  • FDA 510(k) K050994 decided 3 Aug 2005 Active
  • FDA GUDID UDI-DI 00198843003576 listed 24 Jun 2026 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K050994
  2. Listed FDA GUDID 00198843003576
  3. Registered EUDAMED 08479460BTCL

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Infant Flow™
Generic name
Straight/elbow breathing circuit connector, single-use
Device name
Infant Flow LP System
Model / reference
777040M-40
Primary DI / UDI-DI
00198843003576
Basic UDI-DI
08479460BTCL
510(k) Number
FDA product code
BZD
EMDN code
Z1203019085 Various instruments for anaesthesia and pulmonary ventilation support - consumables
GMDN term
Straight/elbow breathing circuit connector, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5905
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
US-MF-000021386
Authorised representative
ZOLL International Holding B.V. NL-AR-000012554

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - CONSUMABLES.

Other devices from Zoll Medical Corporation

See all devices from Zoll Medical Corporation →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)