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Vital Signs™ Breathing Bag, Disposable, 0.5 L

by AirLife Finland Oy

Ref M1036385

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10190752140073 Basic UDI-DI 10190752140073UDI-DIDate13 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number10190752140073 UDI-DI Date6 Jul 2021ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Vital Signs™ Breathing Bag, Disposable, 0.5 L EUDAMED
Vital Signs™ GUDID
Generic Name
Breathing circuit bag, single-use
Device Name
Vital Signs™ Anaesthesia Balloons
Model / Ref / Catalog
M1036385
Primary DI / UDI-DI
10190752140073
Basic UDI-DI
B-10190752140073
FDA Product Code
BTC
EMDN Code
R03020101 Anaesthesia balloons
GMDN Term
Breathing circuit bag, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5320
EU market of registration
Finland
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
FI-MF-000001482

Other devices from AirLife Finland Oy

See all devices from AirLife Finland Oy →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No