ReliOn™ Confirm/Micro Control

Basic Information

• Brand Name: ReliOn™ Confirm/Micro Control
• Primary DI: 00605388710055
• Version / Model: 710005
• Company Name: WAL-MART STORES, INC.
• Labeler DUNS: 051957769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-07
• Public Version: 1
• Public Version Date: 2022-03-15
• Public Version Status: New
• Public Device Record Key: 9681b8ac-8d38-4c4c-9c88-4352fa8e679b

Device Description

ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly. Compare the control solution test result with the range printed on the test strip bottle.

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: Yes
• 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
Primary	00605388710055	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 34 – 86 Degrees Fahrenheit