PTS Panels® Glucose Test Strips (25-ct)

Basic Information

• Brand Name: PTS Panels® Glucose Test Strips (25-ct)
• Primary DI: 00381931713017
• Version / Model: 1713
• Catalog Number: 1713
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 4
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 420f70b2-183d-4ada-9cc7-9e3b2358e62c

Device Description

PTS Panels® glucose test strips are in vitro diagnostic devices used to monitor glucose 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): Yes
• 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
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62538	Glucose 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 glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00381931713017	GS1
Unit of Use	10381931713014	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 28 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight Keep dry
• Type: Storage Environment Temperature
• Temperature Range: 68 – 82 Degrees Fahrenheit