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Affinity Cable and Leadwire System 453561432691

by Affinity Medical Technologies, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00850384007085 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Affinity Cable and Leadwire System
Generic Name
Electrocardiographic lead set, reusable
Model / Reference
453561432691
Primary DI / UDI-DI
00850384007085
FDA Product Code
DSA
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class II
Regulation Number
870.2900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic lead set, reusable

Other devices from Affinity Medical Technologies, LLC

See all devices from Affinity Medical Technologies, LLC →

Properties

  • Lot / Batch Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: 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