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Ideal™ Maxpac® Total System TS1628R1

by Medtronic, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169503557 UDI-DIDate23 Sep 2014ListedStatusListed GUDID: not 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  • Withdrawn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
Ideal™ Maxpac® Total System
Generic Name
Cardiopulmonary bypass system blood tubing set
Model / Reference
TS1628R1
Primary DI / UDI-DI
00643169503557
510(k) Number
FDA Product Code
KFM
GMDN Term
Cardiopulmonary bypass system blood tubing set
Device Class
Class II
Regulation Number
870.4360
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K973011)

Show all (11)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No