50 Dario Blood Glucose Test Strip - The Dario Blood Glucose Test Strips are for use - LABSTYLE INNOVATION LTD

Duns Number:600039072

Device Description: The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quan The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

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More Product Details

Catalog Number

-

Brand Name

50 Dario Blood Glucose Test Strip

Version/Model Number

1024-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150817

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

bde980fe-41ba-4b95-8d17-0c8967cc4828

Public Version Date

June 15, 2021

Public Version Number

5

DI Record Publish Date

June 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LABSTYLE INNOVATION LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 19