DEVICE: CONTOUR® NEXT LINK 2.4 (00301936260019)

Device Identifier (DI) Information

CONTOUR® NEXT LINK 2.4
6260
In Commercial Distribution
6260
ASCENSIA DIABETES CARE US INC.
00301936260019
GS1

1
080028910 *Terms of Use
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; MICROLET® 2 Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; MICROLET® 2 Insert; USB Cable; Wall Charger; Wall Charger Insert; Carrying Case; CONTOUR NEXT® Level 2 control solution. This product may be Bayer branded but is distributed by Ascensia Diabetes Care US, Inc.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
Yes
Yes
No
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.
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FDA Product Code

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Product Code Product Code Name
OZO Artificial Pancreas Device System, Threshold Suspend
OZP Artificial Pancreas Device System, Single Hormonal Control
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P150001 000
P160017 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 48 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c3a40fde-1fa5-4b4e-a9c0-908ced8e77d1
July 06, 2018
3
August 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
18003488100
support@contournext.com
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