DEVICE: CONTOUR® NEXT (00301937283352)
Device Identifier (DI) Information
CONTOUR® NEXT
7283
In Commercial Distribution
7283
ASCENSIA DIABETES CARE US INC.
7283
In Commercial Distribution
7283
ASCENSIA DIABETES CARE US INC.
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
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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. |
FDA Product Code
[?]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 |
Sterilization
Storage and Handling
[?]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
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b1653fc7-fb56-4f31-b79e-5f24d1376209
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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 |
---|---|---|---|---|---|
40301937283350 | 12 | 00301937283352 | In Commercial Distribution | shipper/case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
NDC/NHRIC | 0193-7283-35 |
Unit of Use DI
[?]
Unit of Use DI Number:
00301937283017
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18003488100
support@contournext.com
support@contournext.com