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BiWaze Clear Dual Lumen Circuit - Acute BK909

by Abmrc 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 Number08500501360235 UDI-DI Date20 May 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  • Withdrawn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
BiWaze Clear Dual Lumen Circuit - Acute
Generic Name
Ventilator breathing circuit, reusable
Model / Ref / Catalog
BK909
Primary DI / UDI-DI
08500501360235
FDA Product Code
NHJ
GMDN Term
Ventilator breathing circuit, reusable
Device Class
Class II
Regulation Number
868.5905
GUDID distribution status
In Commercial Distribution

Other devices from Abmrc LLC

See all devices from Abmrc LLC →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No