DEVICE: Element™Plus Meter (08809115908971)

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Device Record History
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Device Identifier (DI) Information
Element™Plus Meter
IGM-0021B
In Commercial Distribution

OSANG HEALTHCARE Co., Ltd.
08809115908971
GS1

1
688195374 *Terms of Use
Blood Glucose Monitoring System
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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
CGA Glucose Oxidase, Glucose
NBW System, Test, Blood Glucose, Over The Counter
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K103021 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 0.3 Microliter
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Device Record Status
83ee92e7-3d8b-450d-a78f-6ceb709eb5f5
July 06, 2018
3
July 21, 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
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 8522-0000-51
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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

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
866-878-7477
xx@xx.xx
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