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Baxter 0601139

by Micromedics, Inc.

Baxter 0601139 is a medical device (FDA Class II; FDA product code FMF, Syringe, Piston) made by Micromedics, Inc., cleared under FDA 510(k) K033589 on 4 Oct 2004 and listed in FDA GUDID since 15 Apr 2021 (UDI-DI 00815634020764), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K033589

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815634020764 UDI-DI Date15 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033589 Date4 Oct 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033589 decided 4 Oct 2004 Active
  • FDA GUDID UDI-DI 00815634020764 listed 15 Apr 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K033589
  2. Listed FDA GUDID 00815634020764

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Baxter
Generic name
Fibrin sealant biochemical preparation/application kit, endoscopic
Model / reference
0601139
Primary DI / UDI-DI
00815634020764
510(k) Number
FDA product code
FMF
GMDN term
Fibrin sealant biochemical preparation/application kit, endoscopic
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fibrin sealant biochemical preparation/application kit, endoscopic

Cleared under the same submission (K033589)

and 2 more cleared under K033589

Similar devices

Other devices filed under FDA product code FMF (Syringe, Piston).

Other devices from Micromedics, Inc.

See all devices from Micromedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)