OneTouch Ultra Blue

Basic Information

• Brand Name: OneTouch Ultra Blue
• Primary DI: 00353885011563
• Version / Model: 011-424
• Catalog Number: 011-424
• Company Name: LifeScan Europe GmbH
• Labeler DUNS: 480240820
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-09-13
• Public Version: 6
• Public Version Date: 2026-04-13
• Public Version Status: Update
• Public Device Record Key: 24bff368-ddee-464d-916f-1169a725b995
• Distribution End Date: 2025-12-04

Device Description

OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters

Device Characteristics

• Single Use: Yes
• 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
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. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20353885011567	GS1	Shipper case	300	Not in Commercial Distribution	2025-12-04
Primary	00353885011563	GS1
Unit of Use	80353885011569	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Use within 6 months of opening test strip vial.
• Type: Storage Environment Temperature
• Temperature Range: High: 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Refrigerate
• Type: Special Storage Condition, Specify
• Special Conditions: Store your test strips in their original vial only.