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N/A 2035W

by Medtronic, Inc.

Listed FDA GUDID listing, no authorization on record

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169957220 UDI-DI Date9 Aug 2019ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-2777-2015 FDA Class II initiated 1 Sep 2015

    An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

    • Terminated Z-1452-06 FDA Unclassified (pre-2012) initiated 4 Aug 2006

    Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Electrocardiographic lead set, reusable
Model / Reference
2035W
Primary DI / UDI-DI
00643169957220
PMA Number
FDA Product Code
LPB
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (P020045)

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