DEVICE: CONTOUR® NEXT (10301937311502)
Device Identifier (DI) Information
CONTOUR® NEXT
7311
In Commercial Distribution
83624710
ASCENSIA DIABETES CARE US INC.
7311
In Commercial Distribution
83624710
ASCENSIA DIABETES CARE US INC.
Blood Glucose Test Strips - 50 Test Strips.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| 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 |
|---|---|
| LFR | Glucose Dehydrogenase, Glucose |
| NBW | System, Test, Blood Glucose, Over The Counter |
| OZO | Artificial Pancreas Device System, Threshold Suspend |
| OZP | Artificial Pancreas Device System, Single Hormonal Control |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K121190 | 000 |
| K160430 | 000 |
| K162336 | 000 |
| K191286 | 000 |
| K193407 | 000 |
| K210687 | 000 |
| K223293 | 000 |
| K241787 | 000 |
| P150001 | 000 |
| P160017 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| 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 Temperature: between 41 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
4dffabd6-74cd-4323-8a0e-16cb816766f0
April 01, 2025
8
August 25, 2016
April 01, 2025
8
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 |
|---|---|---|---|---|---|
| 40301939736502 | 24 | 00301937311505 | 2021-03-18 | Not in Commercial Distribution | case |
| 00301937311505 | 1 | 10301937311502 | In Commercial Distribution | carton | |
| 40301937311503 | 24 | 00301937311505 | In Commercial Distribution | case | |
| 40301935540042 | 4 | 00301937311505 | 2022-03-23 | Not in Commercial Distribution | shipper / speed pack |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| NDC/NHRIC | 0193-7311-50 |
Unit of Use DI
[?]
Unit of Use DI Number:
00301937311017
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18003488100
support@contournext.com
support@contournext.com