Dario USB-C Blood Glucose Monitoring System & Dario Membership - The Dario USB-C Blood Glucose Monitoring System - LABSTYLE INNOVATION LTD

Duns Number:600039072

Device Description: The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose met The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario USB-C meter is connected to a SMD connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C blood glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.Dario USB-C Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. 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

Dario USB-C Blood Glucose Monitoring System & Dario Membership

Version/Model Number

1193-05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150817,K172723

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

c4adb8a7-c083-4db9-9b08-fc0368a01de8

Public Version Date

March 03, 2020

Public Version Number

1

DI Record Publish Date

February 24, 2020

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