CONTOUR® NEXT LINK

Basic Information

• Brand Name: CONTOUR® NEXT LINK
• Primary DI: 00301936203016
• Version / Model: 6203
• Catalog Number: 6203
• Company Name: ASCENSIA DIABETES CARE US INC.
• Labeler DUNS: 080028910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: 229d8dd5-1232-4f4c-aec8-d339fb4efa88

Device Description

Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
LFR	Glucose Dehydrogenase, 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
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. 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
Package	40301936203014	GS1	shipper/case	4	In Commercial Distribution
Primary	00301936203016	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110894	000
K122370	000
K160430	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store test strips between 41°-86°F. Store control solution between 48°-86°F. Keep out of direct sunlight. Do not use after expiration dates.
• Type: Storage Environment Temperature
• Temperature Range: 48 – 86 Degrees Fahrenheit