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PathfinderSL

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
PathfinderSL FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording analyser FDA UDI
Device Name
SENTINEL 10 / PATHFINDER SL KIT SV FDA UDI
Model / Reference
98000 FDA UDI
Description
SENTINEL 10 / PATHFINDER SL KIT SV FDA UDI

Identifiers

Catalog Number
040-1751-00 FDA UDI
Primary DI / UDI-DI
10841522125683 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Electrocardiographic long-term ambulatory recording analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiographic long-term ambulatory recording analyser

PathfinderSL by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording analyser.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI c5ca0bf2-f1d4-4cec-8902-c056d9e871a0 34 fields · synced Jun 1, 2026