FDA.reportPublic FDA data

OneTouch Ultra2

Primary DI
00353885010511
Brand
OneTouch Ultra2
Company
LifeScan Europe GmbH
Model
023-065
Catalog number
023-065
Device description
OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.
Published
2017-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20353885010515PackageGS110Not in Commercial Distribution
00353885010511PrimaryGS10
53885-065-01SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035388501051520353885010515
00353885010511003538850105113538850105110353885010511

GMDN Terms#

Term, Definition table
TermDefinition
Glucose analyser IVD, home-useAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature43 Degrees Fahrenheit111 Degrees Fahrenheit
Special Storage Condition, Specify00Do not refrigerate
Special Storage Condition, Specify00Operating Altitude up to 10000 Feet
Storage Environment Temperature086 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-8862XX@XX.XX

Regulatory Flags#

DUNS number
480240820
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00353885000512OneTouch Ultramini021-211021-2112017-09-13
00353885001311OneTouch Ultramini021-422021-4222017-09-13
00353885002684OneTouch Ultramini021-913021-9132017-09-13
00353885007719OneTouch Verio IQ022-268022-2682017-09-13
00353885007726OneTouch Verio022-269022-2692017-09-13
00353885007733OneTouch Verio022-270022-2702017-09-13
00353885008723OneTouch Verio022-658022-6582017-09-13
00353885008853OneTouch Ultra2021-100021-1002017-09-13
00353885009751OneTouch Verio022-898022-8982017-09-13
00353885009768OneTouch Verio022-899022-8992017-09-13
00353885010016OneTouch Ultra2022-965022-9652017-09-13
00353885010030OneTouch Verio022-978022-9782017-09-13
00353885010481OneTouch Verio023-061023-0612017-09-13
00353885010979OneTouch Verio Flex023-270023-2702017-09-13
00353885011556OneTouch Verio011-817011-8172017-09-13
00353885011563OneTouch Ultra Blue011-424011-4242017-09-13
00353885011570OneTouch Ultra Blue011-424011-4242017-09-13
00353885011679OneTouch Ping023-049023-0492017-12-14
00353885011761OneTouch Verio Flex023-932023-9322018-06-27
00353885012034OneTouch Verio024-174024-1742020-04-12

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05700699461131SC90Radiometer Medical ApSCGA2026-07-09
05700699461605SC90Radiometer Medical ApSCGA2026-07-09
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
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10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
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