FDA.reportPublic FDA data

Smartest Persona II Multi Blood Glucose Monitoring System

Primary DI
00850033167184
Brand
Smartest Persona II Multi Blood Glucose Monitoring System
Company
Globalmed Holdings, LLC
Model
6276
Published
2024-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JIXCalibrator, Multi-Analyte Mixture
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
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
00850033167184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033167184008500331671848500331671840850033167184

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
103201849
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
00085003316723ClinicalAccess® Kiosk1.01CAK0012025-06-26
00850033167221ClinicalAccess Pro Connect1.01CAP001-C01 / 1CAP001-C022025-06-26
00850033167115eNcountereNcounter2023-12-12
00850033167108ClearStethGSW30100103GSW301001032023-12-08
00850033167122Variable Polarizing HoodGMD55100010GMD551000102023-12-08
00850033167139First Exam StationFirst Exam Station2023-12-08
00850033167146Total VitalsUSBGMR507000102023-12-08
00850033167153Total VitalsBluetoothGMR507000202023-12-08
00850033167160Total VitalsDual - BT & USBGMR507000302023-12-08
00850033167177Total ECGGMD50610001GMD506100012023-12-08
00850033167009TotalExam® 3.2 CameraGMD5504HD58GMD5504HD582023-08-04
00850033167016CAS Lite®1CSL0011CSL0012023-08-04
00850033167023TotalExam® Lite, 2.0 GMD5505HD21GMD5505HD212023-08-04
00850033167030TotalExam® Oto 2.0GMD5505HD22GMD5505HD222023-08-04
00850033167047TotalExam® Lite & Oto 2.0GMD5505HD20GMD5505HD202023-08-04
00850033167054Transportable Exam Station (TES)1TES0061TES0062023-08-04
00850033167061Clinical Access® Station (CAS)1CAS0041CAS0042023-08-04
00850033167078WallDoc®1WDC0031WDC0032023-08-04
00850033167085Next Exam Station (NES)GMR12150000GMR121500002023-08-04
00850033167092LiteExam® Station (LES)1LES0011LES0012023-08-04

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Primary DI, Brand, Company table
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00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
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04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON BIORESEARCH INC.NBW2026-07-13
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04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
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