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Oxygen, Bacteria & HEPA Filter OF7000SP-1

by SUNSET HEALTHCARE SOLUTIONS, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848530108755 UDI-DIDate7 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Oxygen, Bacteria & HEPA Filter
Generic Name
CPAP/BPAP unit ambient air filter, reusable
Model / Reference
OF7000SP-1
Primary DI / UDI-DI
00848530108755
FDA Product Code
JRL
GMDN Term
CPAP/BPAP unit ambient air filter, reusable
Device Class
Class I
Regulation Number
862.2050
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

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