DEVICE: ODM (00883489001542)

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Device Record History
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Device Identifier (DI) Information
ODM
iGlucose test strips
In Commercial Distribution
99GS291I51
BIONIME CORPORATION
00883489001542
GS1

25
658637244 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
Yes
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
NBW System, Test, Blood Glucose, Over The Counter
CGA Glucose Oxidase, Glucose
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K161790 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 25 pcs/vial
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Device Record Status
85cb07ac-4b70-4d4b-be50-ec5fea6656d4
July 06, 2018
3
July 19, 2017
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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
00883489001559 2 00883489001542 In Commercial Distribution box
10883489001556 20 00883489001559 In Commercial Distribution case
20883489001553 12 10883489001556 In Commercial Distribution carton
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Secondary DI

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

[?]
Unit of Use DI Number: 80883489001548 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-844-445-8267
support@iglucose.com
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