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Baylab USA 092

by Baylab USA GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850054870704 UDI-DIDate1 Oct 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Baylab USA
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use
Model / Reference
092
Primary DI / UDI-DI
00850054870704
510(k) Number
FDA Product Code
FXX
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use
Device Class
Class II
Regulation Number
878.4040
Commercial Distribution
In Commercial Distribution

Related devices

Cleared under the same submission (K212302)

Other devices from Baylab USA

See all devices from Baylab USA →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • Premarket Exempt: No
  • Serial Number: No