AccessGUDID - DEVICE: CONTOUR® NEXT (00301937283352)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOUR® NEXT
Version or Model: 7283
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7283
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 00301937283352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 35
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)). Formerly distributed in the USA by Bayer HealthCare; now distributed by Ascensia Diabetes Care US, Inc.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
OZO	Artificial Pancreas Device System, Threshold Suspend
NBW	System, Test, Blood Glucose, Over The Counter
LFR	Glucose Dehydrogenase, Glucose
OZP	Artificial Pancreas Device System, Single Hormonal Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121190	000
K160430	000
K162336	000
P150001	000
P160017	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

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Storage and Handling
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store test strips in their original bottle only. Always close the lid immediately and tightly after removing a test strip. Do not use after expiration date.
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1653fc7-fb56-4f31-b79e-5f24d1376209
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016