Skip to content

DiamondTemp™ GenConnect Cable CEDTGC100

by Medtronic, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 ongoing

This device is named in the recall

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 Number00763000482183 UDI-DI Date21 Oct 2021ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1320-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1318-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1317-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1322-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1319-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1321-2021 FDA Class II initiated 22 Feb 2021

    It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
DiamondTemp™ GenConnect Cable
Generic Name
Electrical-only medical device connection cable, reusable
Model / Reference
CEDTGC100
Primary DI / UDI-DI
00763000482183
PMA Number
FDA Product Code
OAE
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (P200028)

Show all (12)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single 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