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Ventilatory Accessory VEN009NS

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 Number00848530109868 UDI-DI Date18 Sep 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  • Withdrawn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
Ventilatory Accessory
Generic Name
Breathing mouthpiece, single-use
Model / Reference
VEN009NS
Primary DI / UDI-DI
00848530109868
FDA Product Code
BYX
GMDN Term
Breathing mouthpiece, single-use
Device Class
Class I
Regulation Number
868.5860
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
  • Expiration Date

Other properties (10)

  • 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
  • Manufacturing Date: No