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Continuous Ventilator V200-0002-PK

by Flight Medical Innovations Ltd

Ref V200-0002-PKModel Flight 60T

Continuous Ventilator V200-0002-PK is a device classified as Class IIb in the EU and Class II in the US made by Flight Medical Innovations Ltd, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-17290013641929), cleared under FDA 510(k) K143035 on 30 Mar 2016 and listed in FDA GUDID since 6 Oct 2017 (UDI-DI 17290013641929), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143035

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-17290013641929 Basic UDI-DI 17290013641929UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17290013641929 UDI-DI Date6 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143035 Date30 Mar 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-17290013641929 registered 30 Sep 2026 Active
  • FDA 510(k) K143035 decided 30 Mar 2016 Active
  • FDA GUDID UDI-DI 17290013641929 listed 6 Oct 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143035
  2. Listed FDA GUDID 17290013641929
  3. Registered EUDAMED B-17290013641929

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Flight 60 EUDAMED
Continuous Ventilator GUDID
Generic name
Transport electric ventilator
Model / reference
V200-0002-PK, Flight 60T
Primary DI / UDI-DI
17290013641929
Basic UDI-DI
B-17290013641929
510(k) Number
FDA product code
NOU, CBK
EMDN code
Z12030104 Portable pulmonary ventilators
GMDN term
Transport electric ventilator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5895
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

Related devices

Category: Transport electric ventilatorAnaesthesia ventilator

Cleared under the same submission (K143035)

and 1 more cleared under K143035

Similar devices in this category

Other devices filed under PORTABLE PULMONARY VENTILATORS.

Other devices from Flight Medical Innovations Ltd

See all devices from Flight Medical Innovations Ltd →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)