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Exactamix H938751

by Baxter Healthcare Corp

Exactamix H938751 is a Class II device made by Baxter Healthcare Corp, cleared under FDA 510(k) K903159 on 7 Nov 1990 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00085412477299), active as of 23 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 23 Oct 2026

Documents

510(k) K903159

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00085412477299 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK903159 Date7 Nov 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K903159 decided 7 Nov 1990 Active
  • FDA GUDID UDI-DI 00085412477299 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K903159
  2. Listed FDA GUDID 00085412477299

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Exactamix
Generic name
Compounding transfer set
Model / Ref / Catalog
H938751
Primary DI / UDI-DI
00085412477299
510(k) Number
FDA product code
LHI
GMDN term
Compounding transfer set
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LHI (Set, i.V. Fluid transfer).

Other devices from Baxter Healthcare Corp

See all devices from Baxter Healthcare Corp →

Properties

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