LABSTYLE INNOVATION LTD

Address:8 Hatokhen St,Caesarea Central,IL

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Device Description : Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing.

Device Class : 1

Duns Number: 600039072

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blo The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancing device cover prevents the user from unintentional punctures.

Device Class : 2

Duns Number: 600039072

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Device Description : The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose The Dario 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 Dariometer 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 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. (DI# 00850065006000)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.(DI#00850065006178)

Device Class : 2

Duns Number: 600039072

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

Device Description : The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood gluc The Dario LC 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 DarioLC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display forthe 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 LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006154)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.(DI#00850065006178)

Device Class : 2

Duns Number: 600039072

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

Device Description : The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood g 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 DarioUSB-C meter is connected to a SMD through USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display forthe 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 glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.

Device Class : 2

Duns Number: 600039072

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Device Description : The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood g 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 DarioUSB-C meter is connected to a SMD through a USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display forthe 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 glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006390)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.(DI#00850065006178)

Device Class : 2

Duns Number: 600039072

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

Device Description : The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose The Dario 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 Dariometer 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 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 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.

Device Class : 2

Duns Number: 600039072

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

Device Description : The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood gluc The Dario LC 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 DarioLC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display forthe 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 LC 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 LC 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.

Device Class : 2

Duns Number: 600039072

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

Device Description : The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood g 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.

Device Class : 2

Duns Number: 600039072

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Device Description : The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Met 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.

Device Class : 2

Duns Number: 600039072

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1