FDA.reportPublic FDA data

OneTouch Ultra2

Primary DI
00353885000277
Brand
OneTouch Ultra2
Company
LifeScan Europe GmbH
Model
021-098
Catalog number
021-098
Device description
OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses 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
20353885000271PackageGS14Not in Commercial Distribution
00353885000277PrimaryGS10
53885-448-01SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035388500027120353885000271
00353885000277003538850002773538850002770353885000277

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30Gauge

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
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719869706966medisana BG 150 Blood Glucose MeterTYSON BIORESEARCH INC.NBW2026-08-19
04719869707000BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707017BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707024BG 150 Blood Glucose Test Strip(50T)TYSON BIORESEARCH INC.NBW2026-08-19
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCCGA2026-08-13
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCNBW2026-08-13
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14