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Pediatric Non-Rebreathing Oxygen Mask R-2960SM

by Canadian Hospital Specialties Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00628725096933 UDI-DI Date23 Feb 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Pediatric Non-Rebreathing Oxygen Mask
Generic Name
Rebreathing oxygen face mask
Model / Reference
R-2960SM
Primary DI / UDI-DI
00628725096933
FDA Product Code
KGB
GMDN Term
Rebreathing oxygen face mask
Device Class
Class I
Regulation Number
868.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rebreathing oxygen face mask

Other devices from Canadian Hospital Specialties Limited

See all devices from Canadian Hospital Specialties Limited →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No