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N/A B101+B102

by Guangzhou Huiming Fibre Products Co., Ltd.

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 Number16979379450093 UDI-DI Date7 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  • Withdrawn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

Generic Name
Isolation gown, single-use
Model / Reference
B101+B102
Primary DI / UDI-DI
16979379450093
FDA Product Code
FQM
GMDN Term
Isolation gown, single-use
Device Class
Class I
Regulation Number
880.5075
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Guangzhou Huiming Fibre Products Co., Ltd.

See all devices from Guangzhou Huiming Fibre Products Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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