OneTouch Ultra Plus

Basic Information

• Brand Name: OneTouch Ultra Plus
• Primary DI: 00353885012645
• Version / Model: 024-272
• Company Name: LifeScan Europe GmbH
• Labeler DUNS: 480240820
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 75
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 1
• Public Version Date: 2022-09-08
• Public Version Status: New
• Public Device Record Key: 5d1c6fc2-3097-4150-a867-54302fcf4f0e

Device Description

OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	80353885012641	GS1
Primary	00353885012645	GS1
Package	20353885012649	GS1	Shipper case	48	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 65 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit