PTS Panels® Creatinine Test Strips

Basic Information

• Brand Name: PTS Panels® Creatinine Test Strips
• Primary DI: 00381931720015
• Version / Model: 1720
• Catalog Number: 1720
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 8
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 36580891-d6f5-45f2-b98b-f671773d14dc
• Distribution End Date: 2019-10-01

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JFY	ENZYMATIC METHOD, CREATININE	Clinical Chemistry	862.1225	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00381931720015	GS1
Unit of Use	10381931720012	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight Keep dry; Bring to room temperature before use
• Type: Storage Environment Temperature
• Temperature Range: 35 – 45 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius