DEVICE: KetoSens (00885325000856)

Device Identifier (DI) Information

KetoSens
276261-201
In Commercial Distribution

i-SENS, Inc.
00885325000856
GS1

1
688840958 *Terms of Use
KetoSens B-Ketone Monitoring System with Lancets
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
Yes
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K170463 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b5ce0c86-49b9-42d5-baef-82082b3de81f
October 18, 2023
3
November 10, 2020
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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
10885325000853 70 00885325000856 In Commercial Distribution Master Case 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: 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

[?]
1-800-429-5001
cs1@i-sens.com
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