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Pneupac

by ICU Medical, Inc. 2 variants

Ref 500-A4843

Active European Union. Also listed in GUDID (US).

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10887709145907 UDI-DI Date4 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0887709PPBracketYN Basic UDI-DI 10887709145907UDI-DIDate16 Apr 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Portable active medical device mount
Device Name
Pneupac™ paraPAC plus™ Mounting Bracket and Clamps
Model / Reference
500-A4843
Primary DI / UDI-DI
10887709145907
Basic UDI-DI
0887709PPBracketYN
FDA Product Code
BTL
EMDN Code
Z1203019080 Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories
GMDN Term
Portable active medical device mount
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.5925
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000009764
Authorised representative
ICU Medical BV NL-AR-000002748

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No