DEVICE: CONTOUR® NEXT (10301937314015)

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Device Record History
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Device Identifier (DI) Information
CONTOUR® NEXT
7314
In Commercial Distribution
83624818
ASCENSIA DIABETES CARE US INC.
10301937314015
GS1

1
080028910 *Terms of Use
Control Solution - Level 2. 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?
41819 Glucose IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
NBW System, Test, Blood Glucose, Over The Counter
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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
c9500339-f8a8-41d0-93af-8e1438eb3f09
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
50301937314013 32 40301937314016 In Commercial Distribution out.shipper/lg.case
40301937314016 12 00301937314018 In Commercial Distribution in.shipper/sm.case
00301937314018 1 10301937314015 In Commercial Distribution carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
NDC/NHRIC 0193-7314-01
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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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