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Oxygen, Bacteria & HEPA Filter BF4000

by SUNSET HEALTHCARE SOLUTIONS, Inc.

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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848530093686 UDI-DI Date19 Oct 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  • Withdrawn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
Oxygen, Bacteria & HEPA Filter
Generic Name
Local/regional anaesthesia conduction filter
Model / Reference
BF4000
Description
Bacteria Intake Filter, Compatible with CAIRE Aspen - EA
Primary DI / UDI-DI
00848530093686
FDA Product Code
CAH
GMDN Term
Local/regional anaesthesia conduction filter
Device Class
Class II
Regulation Number
868.5260
GUDID distribution status
In Commercial Distribution

Other devices from SUNSET HEALTHCARE SOLUTIONS, Inc.

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

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