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Turbo O2 Convenience Kit 100-60-0100

by SharpMed, LLC

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 NumberG3871006001001 UDI-DI Date6 Aug 2026ListedStatusListed 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  • Withdrawn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
Turbo O2 Convenience Kit
Generic Name
Oxygen administration kit
Model / Reference
100-60-0100
Primary DI / UDI-DI
G3871006001001
FDA Product Code
CAI, BYX
GMDN Term
Oxygen administration kit
Device Class
Class I
Regulation Number
868.5240, 868.5860
GUDID distribution status
In Commercial Distribution

Other devices from SharpMed, LLC

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

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