OneTouch Verio IQ

Basic Information

Brand Name: OneTouch Verio IQ
Primary DI: 00353885007719
Version / Model: 022-268
Catalog Number: 022-268
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: 249266ad-1259-4e61-b6cf-1df314be2eee

Device Description

OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing

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
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
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; 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.	No	Active
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
37243	Manual blood lancing device, reusable	A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.	No	Active
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.	No	Active
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
Package	20353885007713	GS1	Shipper case	10	In Commercial Distribution
Primary	00353885007719	GS1
Secondary	53885-854-01	NDC/NHRIC

Customer Contacts

Phone: +1(888)567-3003
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K110637	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	30	Gauge
Device Size Text, specify			Hematocrit 20 - 60%
Device Size Text, specify			Blood Glucose measurement Level mg/dL

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 43 – 111 Degrees Fahrenheit
Type: Storage Environment Temperature
Temperature Range: 41 – 86 Degrees Fahrenheit
Type: Special Storage Condition, Specify
Special Conditions: Operating Altitude up to 10000 Feet
Type: Handling Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity