AccessGUDID - DEVICE: Dario Blood Glucose Monitoring System (00850065006000)

GUDID

Device Identifier (DI) Information

Brand Name: Dario Blood Glucose Monitoring System
Version or Model: 1015-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LABSTYLE INNOVATION LTD

Primary DI Number: 00850065006000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600039072 *Terms of Use

Device Description: The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
47655	Home-use/point-of-care blood glucose/blood pressure monitoring system	A collection of devices designed to semi-quantitatively measure glucose in a specimen of whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. The device is normally available [non-prescription] over-the-counter (OTC) for home-use, but may also be used in a clinical setting for multi-patient monitoring of blood glucose and blood pressure.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150817	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: 93ff127e-4611-4321-8b8c-9b6f0d14ff1a
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: June 12, 2017