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Affinity™ 61399401124

by Medtronic, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00643169858831 UDI-DI Date24 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0693-2020 FDA Class II initiated 14 Nov 2019

    Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Affinity™
Generic Name
Cardiopulmonary bypass system filter, arterial blood line
Model / Reference
61399401124
Primary DI / UDI-DI
00643169858831
510(k) Number
FDA Product Code
DTM
GMDN Term
Cardiopulmonary bypass system filter, arterial blood line
Device Class
Class II
Regulation Number
870.4260
GUDID distribution status
Not in Commercial Distribution
Size
Pore Size — 38.0 Micrometer

Related devices

Cleared under the same submission (K952532)

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