AccessGUDID - DEVICE: CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® NEXT (40301939647518)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® NEXT
Version or Model: 9647
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 85873989
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 40301939647518
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: Mixed product shipper case containing 3 CONTOUR® NEXT ONE Blood Glucose Monitoring System kits (Primary DI Number 00301939763012), 3 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014) and 12 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Primary DI Number 10301937308502).

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):	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 [?]
K111268	000
K121190	000
K130265	000
K160430	000
K160682	000
K162336	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 Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 48 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7263558-ad0a-45b4-8bbe-814cc1616b33
Public Version Date: November 07, 2024
Public Version Number: 4
DI Record Publish Date: November 17, 2017