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Create Biotech 013-001-011

by Create Biotech 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 Number04719874956301 UDI-DI Date21 Jul 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  • Withdrawn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
Create Biotech
Generic Name
Rebreathing oxygen face mask
Model / Reference
013-001-011
Primary DI / UDI-DI
04719874956301
FDA Product Code
BYG
GMDN Term
Rebreathing oxygen face mask
Device Class
Class I
Regulation Number
868.5580
GUDID distribution status
In Commercial Distribution

Other devices from Create Biotech Co., Ltd.

See all devices from Create Biotech Co., Ltd. →

Properties

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

Other properties (8)

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