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Primed PG4-6001

by Primed Medical Products Inc.

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 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842942002496 UDI-DI Date14 Jul 2025ListedStatusListed 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  • Withdrawn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
Primed
Generic name
Surgical/medical face mask, non-antimicrobial, single-use
Model / reference
PG4-6001
Primary DI / UDI-DI
00842942002496
FDA product code
FXX
GMDN term
Surgical/medical face mask, non-antimicrobial, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical face mask, non-antimicrobial, single-use

Other devices from Primed Medical Products Inc.

See all devices from Primed Medical Products Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: 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