AccessGUDID - DEVICE: CONTOUR® (10301939507101)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOUR®
Version or Model: 9507C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6707261
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 10301939507101
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2019
Device Count: 10
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: Blood Glucose Test strips. 10 test strips.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
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
LFR	Glucose Dehydrogenase, Glucose
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062058	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
Special Storage Condition, Specify: Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 49ea120d-c979-4834-a955-e2eb71af314c
Public Version Date: November 06, 2024
Public Version Number: 4
DI Record Publish Date: September 16, 2016