AccessGUDID - DEVICE: Dario LC Blood Glucose Monitoring System & Dario Membership (00850065006451)

GUDID

Device Identifier (DI) Information

Brand Name: Dario LC Blood Glucose Monitoring System & Dario Membership
Version or Model: 1183-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LABSTYLE INNOVATION LTD

Primary DI Number: 00850065006451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600039072 *Terms of Use

Device Description: 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 Dario LC 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 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 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 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
53302	Glucose IVD, kit, enzyme spectrophotometry, rapid	A collection of reagents, and sometimes other associated materials, intended to be used for the quantitative measurement of glucose in a clinical specimen within a short period relative to standard laboratory testing procedures, using an enzyme spectrophotometry method. It is available in a variety of forms (e.g., strips, cartridges, micro-cassettes) and may be used in the laboratory, at the point-of-care, and/or in the home.	Obsolete	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: No CLOSE

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: 2465cb6c-3bd6-4201-bccb-b5fd976da354
Public Version Date: November 14, 2019
Public Version Number: 1
DI Record Publish Date: November 06, 2019