FDA.reportPublic FDA data

OneTouch Ultra2

Primary DI
00353885008372
Brand
OneTouch Ultra2
Company
LifeScan U.S. LLC
Model
021-105
Catalog number
021-105
Device description
OneTouch Ultra2 Blood Glucose Monitoring Meter - Warranty replacement
Published
2017-09-13
Public version status
Update
Distribution status
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
20353885008376PackageGS132In Commercial Distribution
00353885008372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035388500837620353885008376
00353885008372003538850083723538850083720353885008372

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
144895694
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
00353885004183OneTouch Ultra Blue020-963020-9632017-09-13
00353885009713OneTouch Ultra Blue022-895022-8952017-09-13
00353885009720OneTouch Ultra Blue022-896022-8962017-09-13
00353885012652OneTouch Ultra Blue Test Strips024-273024-2732022-07-28
00353885013000OneTouch Ultra024-3912025-06-20
00353885994255OneTouch Ultra Blue020-994020-9942017-09-13
00353885006231OneTouch Ultra021-416021-4162019-11-25
00353885011853OneTouch Ultra2024-046024-0462019-03-12
00353885458023OneTouch Ultra010-458010-4582020-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11