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Flow-Safe II

by Mercury Medical Enterprises, LLC 25 variants

Part of a family of 25 devices: see the family page

Ref 10-57406Model Flow-Safe II CPAP System

Flow-Safe II (10-57406) is a device classified as Class IIa in the EU and Class II in the US made by Mercury Medical Enterprises, LLC, registered in EUDAMED on 23 May 2024 (Basic UDI-DI 0641043FLMU), cleared under FDA 510(k) K090710 on 20 Aug 2009 and listed in FDA GUDID since 14 Jan 2021 (UDI-DI 10641043574065), 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 linked in EUDAMED

A group certificate may exist

510(k) K090710

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 Number0641043FLMU Basic UDI-DI 10641043574065UDI-DIDate23 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number10641043574065 UDI-DI Date14 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK090710 Date20 Aug 2009IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0641043FLMU registered 23 May 2024 Active
  • FDA 510(k) K090710 decided 20 Aug 2009 Active
  • FDA GUDID UDI-DI 10641043574065 listed 14 Jan 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090710
  2. Listed FDA GUDID 10641043574065
  3. Registered EUDAMED 0641043FLMU

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  • Withdrawn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
Flow-Safe II EUDAMED
Flow-Safe II+ BiLevel Disposable CPAP System GUDID
Generic name
CPAP/BPAP nasal mask, single-use
Model / reference
Flow-Safe II CPAP System, 10-57406
Primary DI / UDI-DI
10641043574065
Basic UDI-DI
0641043FLMU
510(k) Number
FDA product code
BYE
EMDN code
R03020201 Manually operated pulmonary resuscitators
GMDN term
CPAP/BPAP nasal mask, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5965
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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-000002015
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Pulmonary resuscitator, manual, single-use

Similar devices in this category

Other devices filed under MANUALLY OPERATED PULMONARY RESUSCITATORS.

Other devices from Mercury Medical Enterprises, LLC

See all devices from Mercury Medical Enterprises, LLC →

Properties

  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)