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OxyTrainer ADVANTAGE 1

by D R Burton Healthcare, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851232007745 UDI-DI Date28 Apr 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  • Withdrawn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
OxyTrainer ADVANTAGE
Generic Name
CPAP/BPAP unit ambient air filter, reusable
Model / Ref / Catalog
1, 565
Primary DI / UDI-DI
00851232007745
FDA Product Code
ION
GMDN Term
CPAP/BPAP unit ambient air filter, reusable
Device Class
Class I
Regulation Number
890.5370
GUDID distribution status
In Commercial Distribution

Other devices from D R Burton Healthcare, LLC

See all devices from D R Burton Healthcare, LLC →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

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