AccessGUDID - DEVICE: OneTouch Verio Blood Glucose Monitoring System. (00353885011808)

GUDID

Device Identifier (DI) Information

Brand Name: OneTouch Verio Blood Glucose Monitoring System.
Version or Model: 024041
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02404101
Company Name: LifeScan Europe GmbH

Primary DI Number: 00353885011808
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480240820 *Terms of Use

Device Description: OneTouch Verio Blood Glucose Monitoring System.

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
LFR	Glucose Dehydrogenase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131363	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
Special Storage Condition, Specify: Do not refrigerate
Special Storage Condition, Specify: Operating Altitude up to 10000 Feet
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Hematocrit 20 - 60%
Device Size Text, specify: Blood Glucose measurement Level mg/dL
Needle Gauge: 30 Gauge

Device Record Status

Public Device Record Key: 114579ae-8a2f-48f2-8f8f-fa5a1caec1a8
Public Version Date: March 21, 2019
Public Version Number: 1
DI Record Publish Date: March 13, 2019