DEVICE: CONTOUR® NEXT (10301937313100)

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Device Record History
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Device Identifier (DI) Information
CONTOUR® NEXT
7313
In Commercial Distribution
83624796
ASCENSIA DIABETES CARE US INC.
10301937313100
GS1

10
080028910 *Terms of Use
Blood Glucose Test Strips - 10 Test Strips.
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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
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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
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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
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
046a287f-adfb-41f8-956a-7a448b73f143
April 01, 2025
7
August 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
40301937313101 24 00301937313103 In Commercial Distribution case
00301937313103 1 10301937313100 In Commercial Distribution carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
NDC/NHRIC 0193-7313-10
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Unit of Use DI

[?]
Unit of Use DI Number: 00301937313011 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
18003488100
support@contournext.com
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