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Visubreath Sticker

by Affirm Medical Technologies II, LLC

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 Number00884400815477 UDI-DI Date5 Aug 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  • Withdrawn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
Visubreath
Generic Name
Capnography oxygen mask
Model / Reference
Sticker
Primary DI / UDI-DI
00884400815477
FDA Product Code
CCK
GMDN Term
Capnography oxygen mask
Device Class
Class II
Regulation Number
868.1400
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Affirm Medical Technologies II, LLC

  • VisuBreath

    Class II

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No