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PathfinderSL - PathfinderSL

by Spacelabs Healthcare (Washington), Inc

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 Number10841522103209 UDI-DI Date15 Aug 2017ListedStatusListed 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  • Withdrawn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; SENTINEL
Generic Name
Electrocardiographic long-term ambulatory recording analyser
Model / Ref / Catalog
98000, 98200, NAVPLUS, 043-0129-00
Primary DI / UDI-DI
10841522103209
FDA Product Code
DQK
GMDN Term
Electrocardiographic long-term ambulatory recording analyser
Models / Variants
PathfinderSL
Device Class
Class II
Regulation Number
870.1425
GUDID distribution status
Not in Commercial Distribution

Other devices from Spacelabs Healthcare (Washington), Inc

See all devices from Spacelabs Healthcare (Washington), 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