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CPAP Headgear HG206

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848530109080 UDI-DI Date4 Jun 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  • Withdrawn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
CPAP Headgear
Generic Name
CPAP/BPAP face mask, reusable
Model / Reference
HG206
Primary DI / UDI-DI
00848530109080
FDA Product Code
BTK
GMDN Term
CPAP/BPAP face mask, reusable
Device Class
Class I
Regulation Number
868.5560
GUDID distribution status
In Commercial Distribution

Other devices from SUNSET HEALTHCARE SOLUTIONS, Inc.

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Properties

  • Single Use
  • Premarket Exempt

Other properties (12)

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