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PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECE 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 Number00851232007585 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  • Withdrawn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
PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECE
Generic Name
Incentive spirometer
Model / Ref / Catalog
1, 533
Primary DI / UDI-DI
00851232007585
510(k) Number
FDA Product Code
BWF
GMDN Term
Incentive spirometer
Device Class
Class II
Regulation Number
868.5690
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K160636)

Other devices from D R Burton Healthcare, LLC

See all devices from D R Burton Healthcare, LLC →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: 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