Skip to content

Puritan Bennett 980A3ENNISB

by Covidien LP EUDAMEDGUDID

Active European Union

Ref 980A3ENNISB

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00004477U Basic UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521201910 UDI-DIDate31 Aug 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Puritan Bennett
Generic Name
Neonatal/adult intensive-care ventilator
Device Name
Puritan Bennett 980 Ventilator System
Model / Reference
980A3ENNISB
Primary DI / UDI-DI
10884521201910
Basic UDI-DI
0763000B00004477U
FDA Product Code
CBK
EMDN Code
Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
GMDN Term
Neonatal/adult intensive-care ventilator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5895
Market of Registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Covidien LP

See all devices from Covidien LP →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No