OneTouch Ultramini

Basic Information

Brand Name: OneTouch Ultramini
Primary DI: 00353885000512
Version / Model: 021-211
Catalog Number: 021-211
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: b2afd28e-ee85-4582-9f99-0b089b4cfcd1

Device Description

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip

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

GMDN Terms

Code	Name	Definition	Implantable	Status
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
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
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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status
Package	20353885000516	GS1	Shipper case	10	In Commercial Distribution
Primary	00353885000512	GS1
Secondary	53885-211-01	NDC/NHRIC

Customer Contacts

Phone: +1(800)227-8862
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061118	000

Device Sizes

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

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 43 – 111 Degrees Fahrenheit
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: Storage Environment Temperature
Temperature Range: High: 86 Degrees Fahrenheit
Type: Special Storage Condition, Specify
Special Conditions: Do not refrigerate