AccessGUDID - DEVICE: CONTOUR® PLUS BLUE (00301937035012)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOUR® PLUS BLUE
Version or Model: 7035
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 90006207
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 00301937035012
Issuing Agency: GS1
Commercial Distribution End Date: January 06, 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 Plus Blue blood glucose meter (Product of Indonesia) -10 Contour Plus blood glucose test strips (Product of Japan) -Microlet Next lancing device (Product of Poland) -10 Microlet lancets (Product of Poland) -User Guide -Quick Reference Guide -Carrying Case (Product of China) Contour Plus control solution (Product of USA)"

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 [?]
K231679	000
K241787	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: c8c4e4f9-f40a-4f64-96cd-92a4372ff8d2
Public Version Date: April 01, 2025
Public Version Number: 4
DI Record Publish Date: May 30, 2024