PathfinderSL v1.9.x

GUDID 10841522124617

CD ASSY PATHFINDER SL 1.9

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiographic long-term ambulatory recording analyser
Primary Device ID10841522124617
NIH Device Record Keyee4462c6-407e-4b94-bcf5-d0d56f3b5177
Commercial Distribution StatusIn Commercial Distribution
Brand NamePathfinderSL
Version Model Number98000
Catalog Numberv1.9.x
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522124617 [Primary]

FDA Product Code

DQKComputer, diagnostic, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-15
Device Publish Date2019-01-29

On-Brand Devices [PathfinderSL]

10841522125638SENTINEL 10 / PATHFINDER SL KIT EN
10841522125737SENTINEL 10 / PATHFINDER SL KIT DE
10841522125720SENTINEL 10 / PATHFINDER SL KIT DN
10841522125706SENTINEL 10 / PATHFINDER SL KIT BR-PT
10841522125690SENTINEL 10 / PATHFINDER SL KIT PL
10841522125683SENTINEL 10 / PATHFINDER SL KIT SV
10841522125676SENTINEL 10 / PATHFINDER SL KIT ES
10841522125669SENTINEL 10 / PATHFINDER SL KIT IT
10841522125652SENTINEL 10 / PATHFINDER SL KIT FR
10841522125102PATHFINDER SL KIT CN
10841522124617CD ASSY PATHFINDER SL 1.9
10841522125713SENTINEL 10 / PATHFINDER SL KIT NL

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