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TRILLIUM® Affinity NT® 95215

by Medtronic, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994865977 UDI-DI Date16 Jun 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-0476-2008 FDA Unclassified (pre-2012) initiated 1 Oct 2007

    Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin

    • Terminated Z-0815-04 FDA Unclassified (pre-2012) initiated 25 Mar 2004

    An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TRILLIUM® Affinity NT®
Generic Name
Extracorporeal membrane oxygenator
Model / Reference
95215
Primary DI / UDI-DI
00613994865977
510(k) Number
FDA Product Code
DTZ
GMDN Term
Extracorporeal membrane oxygenator
Device Class
Class II
Regulation Number
870.4350
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K973760)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

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

Other properties (10)

  • 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