AccessGUDID - DEVICE: OneTouch Ultra2 Blood Glucose Monitoring System. (00353885011860)

GUDID

Device Identifier (DI) Information

Brand Name: OneTouch Ultra2 Blood Glucose Monitoring System.
Version or Model: 024-047
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 024-047
Company Name: LifeScan Europe GmbH

Primary DI Number: 00353885011860
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480240820 *Terms of Use

Device Description: OneTouch Ultra2 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
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 43 and 111 Degrees Fahrenheit
Storage Environment Temperature: less than 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Do not refrigerate
Device Size Text, specify: Hematocrit 30 - 55%
Device Size Text, specify: Blood Glucose measurement Level mg/dL
Needle Gauge: 30 Gauge

Device Record Status

Public Device Record Key: 87fafd02-6e3f-4e6a-b463-40497834894e
Public Version Date: September 02, 2022
Public Version Number: 2
DI Record Publish Date: March 12, 2019