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Na 5J95R4

by Medtronic, Inc.

Listed FDA GUDID listing, no authorization on record

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000117047 UDI-DI Date12 Mar 2018ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0535-2018 FDA Class II initiated 3 Jan 2018

    Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Cardiopulmonary bypass system blood tubing set
Model / Reference
5J95R4
Primary DI / UDI-DI
00763000117047
510(k) Number
FDA Product Code
DWF
GMDN Term
Cardiopulmonary bypass system blood tubing set
Device Class
Class II
Regulation Number
870.4210
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiopulmonary bypass system blood tubing set

Cleared under the same submission (K171308)

Show all (12)

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