DEVICE: CONTOUR® NEXT LINK 2.4 (00301936262013)
Device Identifier (DI) Information
CONTOUR® NEXT LINK 2.4
6262
In Commercial Distribution
6262
ASCENSIA DIABETES CARE US INC.
6262
In Commercial Distribution
6262
ASCENSIA DIABETES CARE US INC.
Wireless Blood Glucose Monitoring System. 1 Kit.
For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
---|---|
OZO | Artificial Pancreas Device System, Threshold Suspend |
OZP | Artificial Pancreas Device System, Single Hormonal Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P150001 | 000 |
P160017 | 000 |
Sterilization
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
a0ce089f-a3ff-41d9-8333-6278996b77a3
June 07, 2019
5
August 25, 2016
June 07, 2019
5
August 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
NDC/NHRIC | 0193-6262-01 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18003488100
support@contournext.com
support@contournext.com