FDA.reportPublic FDA data

OneTouch Verio

Primary DI
20353885012427
Brand
OneTouch Verio
Company
LifeScan Europe GmbH
Model
013-046
Device description
OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing.
Published
2021-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110637000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110637000ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEMCilag GmbH International2011-09-07LFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20353885012427PackageGS1450In Commercial Distribution
00353885012423PrimaryGS10
80353885012429Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035388501242720353885012427
00353885012423003538850124233538850124230353885012423
8035388501242980353885012429

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480240820
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00021292015381TRUE METRIX PROTRIVIDIA HEALTH, INC.LFR2025-12-02
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
00301939628021CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2025-01-06
00353885012836OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2024-01-31
00850044118250iHealthiHealth Labs Inc.LFR2023-08-30
00850044118267iHealthiHealth Labs Inc.LFR2023-08-30
00850044118205iHealthiHealth Labs Inc.LFR2023-08-24
00353885012799OneTouch Verio FlexLifeScan Europe GmbHLFR2023-05-26
40301939660517CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXTASCENSIA DIABETES CARE US INC.LFR2022-11-23
00353885012102OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012621OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012638OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012645OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012683OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012485OneTouch Verio FlexLifeScan Europe GmbHLFR2022-05-19
00301937828010CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2022-01-07
00301939550018CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-12-08
00301937825019CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-11-22
00353885012423OneTouch VerioLifeScan Europe GmbHLFR2021-09-18
00021292014797TRUE METRIXTRIVIDIA HEALTH, INC.LFR2021-08-06
00301937553011CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2021-07-30
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
00353885012188OneTouch VerioLifeScan Europe GmbHLFR2020-06-30
50096295139551TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-05-11
00357599807009FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00357599808006FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00353885012034OneTouch VerioLifeScan Europe GmbHLFR2020-04-12