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Trulink ECG Cables & Leadwires

by Spacelabs Healthcare (Washington), Inc 76 variants

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841522101588 UDI-DI Date3 May 2017ListedStatusListed 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  • Withdrawn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
Trulink
Generic Name
Electrocardiographic lead set, reusable
Model / Ref / Catalog
ECG Cables & Leadwires, 012-0296-04
Primary DI / UDI-DI
10841522101588
FDA Product Code
MHX
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class II
Regulation Number
870.1025
GUDID distribution status
In Commercial Distribution

Other devices from Spacelabs Healthcare (Washington), Inc

See all devices from Spacelabs Healthcare (Washington), Inc →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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