AccessGUDID - DEVICE: PTS Panels® Creatinine Test Strips (00381931720015)

GUDID

Device Identifier (DI) Information

Brand Name: PTS Panels® Creatinine Test Strips
Version or Model: 1720
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1720
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381931720015
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2019
Device Count: 25
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: PTS Panels® Creatinine test strips are in vitro diagnostic devices used to monitor creatinine levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
64382	Creatinine monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of creatinine singularly in a whole blood clinical specimen. Measured creatinine values are typically used to monitor kidney function in persons with diabetes mellitus or kidney disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFY	ENZYMATIC METHOD, CREATININE

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
Special Storage Condition, Specify: Keep away from sunlight Keep dry; Bring to room temperature before use
Storage Environment Temperature: between 35 and 45 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36580891-d6f5-45f2-b98b-f671773d14dc
Public Version Date: July 31, 2023
Public Version Number: 8
DI Record Publish Date: July 15, 2016