OneTouch Ultra2

Basic Information

• Brand Name: OneTouch Ultra2
• Primary DI: 00353885010016
• Version / Model: 022-965
• Catalog Number: 022-965
• Company Name: LifeScan Europe GmbH
• Labeler DUNS: 480240820
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-13
• Public Version: 4
• Public Version Date: 2019-07-26
• Public Version Status: Update
• Public Device Record Key: aee8f17d-5282-47a9-99e4-fc16ad1249df

Device Description

OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. Not for Resale or Reimbursement

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	Clinical Chemistry	862.1345	2
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20353885010010	GS1	Shipper case	10	In Commercial Distribution
Primary	00353885010016	GS1
Secondary	53885-296-01	NDC/NHRIC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K053529	000

Device Sizes

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Do not refrigerate
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Operating Altitude up to 10000 Feet
• Type: Handling Environment Temperature
• Temperature Range: 43 – 111 Degrees Fahrenheit