AccessGUDID - DEVICE: Dario® USB-C Blood Glucose Monitoring System (2025)

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Device Record History

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Device Identifier (DI) Information

Brand Name:Dario® USB-C Blood Glucose Monitoring System - Starter Kit
Version or Model:1265-05
Commercial Distribution Status:In Commercial Distribution
Catalog Number:
Company Name:LABSTYLE INNOVATION LTD

Primary DI Number:00850065006758
Issuing Agency:GS1
Commercial Distribution End Date:
Device Count:1
Labeler D-U-N-S® Number*:600039072 *Terms of Use

Device Description: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 through a USB-C 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 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# 00850065006741)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 Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status[?]	Implantable?
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	Active	false

FDA Product Code[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150817	000
K172723	000

Device Exempt from Premarket Submission:NoCLOSE

Sterilization

Device Packaged as Sterile:No
Requires Sterilization Prior to Use:No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key:94939b21-228e-43b6-ae40-4e851e25a6cc
Public Version Date:December 29, 2023
Public Version Number:1
DI Record Publish Date:December 21, 2023

Alternative and Additional IdentifiersAdditional Identifiers

Package DI[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI[?]

Issuing Agency[?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI[?]

Unit of Use DI Number: No Unit of Use DI Numbers FoundCLOSE

Direct Marking (DM)[?]

Device Subject to Direct Marking (DM), but Excepted:Yes
DM DI Different from Primary DI:No
DM DI Number:None
CLOSE

Production Identifier(s) in UDI[?]

Lot or Batch Number:Yes
Serial Number:Yes
Expiration Date:Yes
Manufacturing Date:Yes
Donation Identification Number:NoCLOSE

Customer Contact[?]

No Customer Contact currently defined