Dario USB-C Blood Glucose Monitoring System & Dario Membership

GUDID 00850065006505

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.

LABSTYLE INNOVATION LTD

Glucose IVD, kit, enzyme spectrophotometry, rapid
Primary Device ID00850065006505
NIH Device Record Keyc4adb8a7-c083-4db9-9b08-fc0368a01de8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDario USB-C Blood Glucose Monitoring System & Dario Membership
Version Model Number1193-05
Company DUNS600039072
Company NameLABSTYLE INNOVATION LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850065006505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-03
Device Publish Date2020-02-24

Devices Manufactured by LABSTYLE INNOVATION LTD

00850065006741 - Dario® USB-C Blood Glucose Monitoring System- Welcome Kit2023-12-29 The Dario USB-C Blood Glucose Monitoring System Welcome Kit is a compact, all-in-one blood glucose meter that is used in conjunc
00850065006758 - Dario® USB-C Blood Glucose Monitoring System - Starter Kit2023-12-29 The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a
00850033352023 - Dario Smart Scale (Cellular) - Weight Management System2021-10-25 The Dario Smart Scale (Cellular) - Weight Management System is intended for measuring the body weight of adults and children (ag
00850065006222 - Dario 100 Sterile Lancets2021-08-18 The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancin
00850033352009 - Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System2021-08-17 The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pr
00850065006659 - Dario Super Saver MIB-Supplies2021-07-23
00850065006567 - Dario 300 Test Strips Bundle2020-09-03 The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in
00850065006574 - Dario 200 Test Strips Bundle2020-09-03 The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in

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