OneTouch Verio

Basic Information

• Brand Name: OneTouch Verio
• Primary DI: 00353885010030
• Version / Model: 022-978
• Catalog Number: 022-978
• Company Name: LifeScan Europe GmbH
• Labeler DUNS: 480240820
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• 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: fac5fd32-40be-4166-a229-0937ee22041a

Device Description

OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters.For DME Beneficiaries Only

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
LFR	Glucose dehydrogenase, glucose	Clinical Chemistry	862.1345	2
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20353885010034	GS1	Shipper case	240	In Commercial Distribution
Primary	00353885010030	GS1
Unit of Use	80353885010036	GS1
Secondary	53885-838-01	NDC/NHRIC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110637	000
K120708	000
K131363	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Discard 6 months after opening
• Type: Special Storage Condition, Specify
• Special Conditions: Store your test strips in the vial only