UniStrip1 Generic Blood Glucose Test Strip

Basic Information

• Brand Name: UniStrip1 Generic Blood Glucose Test Strip
• Primary DI: 00389167248501
• Version / Model: 024850
• Catalog Number: 024850
• Company Name: Unistrip Technologies, LLC
• Labeler DUNS: 043251054
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2023-09-27
• Public Version Status: Update
• Public Device Record Key: 6871fe86-34a6-44b9-b928-2319ffc4aabe

Device Description

UniStrip1 Generic Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchased before October 2012.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00389167348508	GS1	Corrugated Carton	24	In Commercial Distribution
Primary	00389167248501	GS1
Unit of Use	00389167148504	GS1