AccessGUDID - DEVICE: PathfinderSL (10841522103087)

GUDID

Device Identifier (DI) Information

Brand Name: PathfinderSL
Version or Model: 98000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 040-1708-00
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522103087
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: SENTINEL 10 / PATHFINDER SL KIT EN

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36827	Electrocardiographic long-term ambulatory recording analyser	An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd65f725-449a-413f-8be6-05c4dba9f8ab
Public Version Date: August 31, 2018
Public Version Number: 5
DI Record Publish Date: February 13, 2017