FDA.reportPublic FDA data

Smartest Persona II Multi Blood Glucose Monitoring System

Primary DI
04712803564141
Brand
Smartest Persona II Multi Blood Glucose Monitoring System
Company
OK BIOTECH CO., LTD.
Model
6276
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133509000EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOOBiotest Medical Corp.2014-02-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712803566060PackageGS11In Commercial Distribution
04712803568095PackageGS11In Commercial Distribution
04712803569269PackageGS11In Commercial Distribution
04712803564141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712803566060047128035660604712803566060
04712803568095047128035680954712803568095
04712803569269047128035692694712803569269
04712803564141047128035641414712803564141

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, point-of-careA collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658796458
Device count
1
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
00193169642300TruePoint64230642302018-09-28
00852169003015Perfect 3 Multi Blood Glucose Test StripsOK1M2023-08-23
00193169642324TruePoint64232642322018-12-03
00193169642331TruePoint64233642332018-12-03
00193169642348TruePoint64234642342018-12-03
00193169642362TruePoint64236642362018-12-03
00193169642409TruePoint64240642402018-12-03
00193169001602OKB OTC Hearing AidGV-SA03.6030-81-0300-01032025-07-01
00193169003507OKB OTC Hearing Aid - Bluetooth EarphonesHT00130-81-0300-03032025-07-01
00193169642003TruePoint64200642002025-06-05
10193169642307TruePoint64230642302018-09-28

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Primary DI, Brand, Company table
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