CONTOUR® NEXT ONE, CONTOUR® NEXT and MICROLET®

Basic Information

• Brand Name: CONTOUR® NEXT ONE, CONTOUR® NEXT and MICROLET®
• Primary DI: 40301939780512
• Version / Model: 9780
• Catalog Number: 9780
• Company Name: ASCENSIA DIABETES CARE US INC.
• Labeler DUNS: 080028910
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-06
• Public Version: 3
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: d528dc7e-5ca8-4321-9a1f-259684503de2
• Distribution End Date: 2021-03-26

Device Description

Mixed product shipper case containing 1 CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Number 00301937818011), 3 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 300 MICROLET® lancets (provided sterile).

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: Yes
• 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
FMK	Lancet, Blood	General, Plastic Surgery	878.4850	2
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
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.	No	Active
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
Primary	40301939780512	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity