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OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETER 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

None found

in data synced 22 Oct 2026

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 Number00851232007158 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETER
Generic Name
Airway pressure monitor, non-powered
Model / Ref / Catalog
1, 563-TS, 563-6
Primary DI / UDI-DI
00851232007158
510(k) Number
FDA Product Code
BWF, CAP
GMDN Term
Airway pressure monitor, non-powered
Device Class
Class II
Regulation Number
868.5690, 868.2600
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K192000)

Other devices from D R Burton Healthcare, LLC

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Properties

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

Other properties (10)

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