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PathfinderSL 98000

by Spacelabs Healthcare (Washington), Inc 20 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number10841522125058 UDI-DI Date19 Jun 2018ListedStatusListed GUDID: not 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  • Withdrawn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
PathfinderSL
Generic Name
Electrocardiographic long-term ambulatory recording analyser
Model / Ref / Catalog
98000, 040-1752-00
Primary DI / UDI-DI
10841522125058
FDA Product Code
DQK
GMDN Term
Electrocardiographic long-term ambulatory recording analyser
Device Class
Class II
Regulation Number
870.1425
GUDID distribution status
Not in Commercial Distribution

Other devices from Spacelabs Healthcare (Washington), Inc

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Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No