UniStrip Control Solution Low

Basic Information

• Brand Name: UniStrip Control Solution Low
• Primary DI: 00389167362108
• Version / Model: 036210
• Catalog Number: 036210
• Company Name: Unistrip Technologies, LLC
• Labeler DUNS: 043251054
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2023-09-27
• Public Version Status: Update
• Public Device Record Key: 5c59d994-53d9-4f30-bc80-de28235e79bf

Device Description

UniStrip Control Solution Low 4mL

Device Characteristics

• Single Use: No
• 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: 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00389167262101	GS1	Corrugated Carton	1000	In Commercial Distribution
Primary	00389167362108	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.