FDA UDI In Commercial Distribution 🇺🇸 United States

PathfinderSL

DI: 10841522125638 · Model: 98000 · SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PathfinderSL
Primary DI
10841522125638
Version / Model
98000
Catalog Number
040-1708-00
Company Name
SPACELABS HEALTHCARE (WASHINGTON), INC
Labeler DUNS
145581588
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-03
Public Version
9
Public Version Date
2020-04-15
Public Version Status
Update
Public Device Record Key
2b4d563e-98d8-41de-a0c4-aa8779d31a08

Device Description

SENTINEL 10 / PATHFINDER SL KIT EN

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE

GMDN Terms

Code Name
36827 Electrocardiographic long-term ambulatory recording analyser

Identifiers

Type ID
Primary 10841522125638