AccessGUDID - DEVICE: CONTOUR® NEXT GEN (00301939732018)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOUR® NEXT GEN
Version or Model: 9732
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 90010386
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 00301939732018
Issuing Agency: GS1
Commercial Distribution End Date: January 20, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOUR® NEXT blood glucose test strips, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, CONTOUR® NEXT control solution"

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223293	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 48 and 86 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ebf95b15-0769-4486-bab0-5c71f2867620
Public Version Date: January 21, 2025
Public Version Number: 2
DI Record Publish Date: July 21, 2023