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AMBU Hyperinflation System 900 000 604

by Westmed, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889483542835 UDI-DIDate5 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
AMBU Hyperinflation System
Generic Name
Pulmonary resuscitator, manual, single-use
Model / Reference
900 000 604
Primary DI / UDI-DI
10889483542835
FDA Product Code
BZR
GMDN Term
Pulmonary resuscitator, manual, single-use
Device Class
Class II
Regulation Number
868.5330
GUDID distribution status
In Commercial Distribution

Other devices from Westmed, Inc.

See all devices from Westmed, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No