AccessGUDID - DEVICE: OneTouch Ultra2 (00353885010016)

GUDID

Device Identifier (DI) Information

Brand Name: OneTouch Ultra2
Version or Model: 022-965
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 022-965
Company Name: LifeScan Europe GmbH

Primary DI Number: 00353885010016
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. Uses the OneTouch Ultra Blue Test Strip. Not for Resale or Reimbursement

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?
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	Active	false
62645	Glucose analyser IVD, home-use	An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; 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. This analyser is typically included in a blood glucose monitoring system.	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 [?]
K053529	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
Storage Environment Temperature: less than 86 Degrees Fahrenheit
Special Storage Condition, Specify: Do not refrigerate
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Operating Altitude up to 10000 Feet
Handling Environment Temperature: between 43 and 111 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Hematocrit 30 - 55%
Device Size Text, specify: Blood Glucose measurement Level mg/dL

Device Record Status

Public Device Record Key: aee8f17d-5282-47a9-99e4-fc16ad1249df
Public Version Date: June 19, 2025
Public Version Number: 5
DI Record Publish Date: September 13, 2017