DEVICE: CONTOUR® NEXT (10301937315012)

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Device Record History
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Device Identifier (DI) Information
CONTOUR® NEXT
7315
In Commercial Distribution
83624826
ASCENSIA DIABETES CARE US INC.
10301937315012
GS1

1
080028910 *Terms of Use
Control Solution - Level 1. 1 x 2.5 mL.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K121190 000
K151742 000
K160430 000
K160682 000
K162336 000
K191286 000
K193407 000
K210687 000
K223293 000
K241787 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 48 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Do not use after expiration date.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
1b0add37-248b-4793-b13c-160612f45feb
April 01, 2025
6
September 16, 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
50301937315010 32 40301937315013 In Commercial Distribution out.shipper/lg.case
40301937315013 12 00301937315015 In Commercial Distribution in.shipper/sm.case
00301937315015 1 10301937315012 In Commercial Distribution carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
NDC/NHRIC 0193-7315-01
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Unit of Use DI

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
18003488100
support@contournext.com
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