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Na 11M02R2

by Medtronic, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

25 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 Number00763000437367 UDI-DI Date10 Oct 2020ListedStatusListed GUDID: in commercial distribution

Recalls

25 recalls · FDA

  • 25 recalls, same reason

    • Terminated Z-1881-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1893-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1872-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1879-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1887-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1874-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1895-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1886-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1876-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1894-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1877-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1882-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1889-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1884-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1871-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1891-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1892-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1873-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1875-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1878-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1885-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1890-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1883-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1888-2021 FDA Class II initiated 29 Apr 2021
    • Terminated Z-1880-2021 FDA Class II initiated 29 Apr 2021

    Specific lots may have been manufactured with insufficient or incomplete welds.

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  • Withdrawn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
11M02R2
Primary DI / UDI-DI
00763000437367
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 (K171979)

Show all (12)

Other devices from Medtronic, Inc.

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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