FDA.reportPublic FDA data

OneTouch Verio

Primary DI
20353885010485
Brand
OneTouch Verio
Company
LifeScan Europe GmbH
Model
023-061
Catalog number
023-061
Device description
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters. For Kaiser Permanente Members Only
Published
2017-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical 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
20353885010485PackageGS1120In Commercial Distribution
00353885010481PrimaryGS10
53885-061-50SecondaryNDC/NHRIC0
80353885010487Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035388501048520353885010485
00353885010481003538850104813538850104810353885010481
8035388501048780353885010487

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Discard 6 months after opening
Special Storage Condition, Specify00Store your test strips in the vial only
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)567-3003XX@XX.XX

Regulatory Flags#

DUNS number
480240820
Device count
100
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

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