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Trillium™ Bio-Pump+™ BPX-80T

by Medtronic, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00643169630628 UDI-DI Date3 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Trillium™ Bio-Pump+™
Generic name
Cardiopulmonary bypass system centrifugal pump
Model / reference
BPX-80T
Primary DI / UDI-DI
00643169630628
510(k) Number
FDA product code
KFM
GMDN term
Cardiopulmonary bypass system centrifugal pump
Device class
Class II
Regulation number
870.4360
GUDID distribution status
Not in Commercial Distribution
Size
Lumen/Inner Diameter — 9.53 Millimeter

Other devices from Medtronic, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number

Other properties (11)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No