DEVICE: Dario Blood Glucose Monitoring System (00850065006000)

Device Identifier (DI) Information

Dario Blood Glucose Monitoring System
1015-01
In Commercial Distribution

LABSTYLE INNOVATION LTD
00850065006000
GS1

1
600039072 *Terms of Use
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Home-use/point-of-care blood glucose/blood pressure monitoring system A collection of devices designed to semi-quantitatively measure glucose in a specimen of whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. The device is normally available [non-prescription] over-the-counter (OTC) for home-use, but may also be used in a clinical setting for multi-patient monitoring of blood glucose and blood pressure.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150817 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
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Device Record Status

93ff127e-4611-4321-8b8c-9b6f0d14ff1a
July 06, 2018
4
June 12, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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