AccessGUDID - DEVICE: 50 Dario Blood Glucose Test Strip (00850065006017)

GUDID

Device Identifier (DI) Information

Brand Name: 50 Dario Blood Glucose Test Strip
Version or Model: 1024-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LABSTYLE INNOVATION LTD

Primary DI Number: 00850065006017
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 600039072 *Terms of Use

Device Description: 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 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:	No
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?
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
CGA	Glucose Oxidase, Glucose

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: bde980fe-41ba-4b95-8d17-0c8967cc4828
Public Version Date: June 15, 2021
Public Version Number: 5
DI Record Publish Date: June 12, 2017