DEVICE: KetoSens (00885325000856)
Device Identifier (DI) Information
KetoSens
276261-201
In Commercial Distribution
i-SENS, Inc.
276261-201
In Commercial Distribution
i-SENS, Inc.
KetoSens B-Ketone Monitoring System with Lancets
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No | |
Yes | |
Yes | |
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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? |
---|---|---|---|---|
62643 | Multiple clinical chemistry analyte monitoring system IVD, home-use |
A collection of devices including a portable, electrically-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 together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K170463 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b5ce0c86-49b9-42d5-baef-82082b3de81f
October 18, 2023
3
November 10, 2020
October 18, 2023
3
November 10, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10885325000853 | 70 | 00885325000856 | In Commercial Distribution | Master Case Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-429-5001
cs1@i-sens.com
cs1@i-sens.com