FDA.reportPublic FDA data

GE

Primary DI
00883489000873
Brand
GE
Company
BIONIME CORPORATION
Model
GP200
Published
2016-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JQPCalculator/Data Processing Module, For Clinical Use
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113007000BIONIME DIABETES MANAGEMENT SYSTEM VI.0Bionime Corporation2012-02-27JQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883489001481PackageGS11In Commercial Distribution
10883489001488PackageGS120In Commercial Distribution
20883489001485PackageGS13In Commercial Distribution
00883489000873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883489001481008834890014818834890014810883489001481
1088348900148810883489001488
2088348900148520883489001485
00883489000873008834890008738834890008730883489000873

GMDN Terms#

Term, Definition table
TermDefinition
Home-use/point-of-care blood glucose monitoring system IVDA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Regulatory Flags#

DUNS number
658637244
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883489002655iGlucose Touch Blood Glucose MeteriGlucose Touch 2025-12-04
00883489002679iGlucose Touch Blood Glucose Test StripiGlucose Touch 2025-12-04
00883489002693iGlucose Touch Control SolutionGC7002025-12-04
00883489002662iGlucose Touch Blood Glucose MeteriGlucose Touch 2025-12-04
00883489002686iGlucose Touch Blood Glucose Test StripiGlucose Touch 2025-12-04
00883489002709iGlucose Touch Control SolutionGC7002025-12-04
00883489002594RIGHTEST Blood Glucose Monitoring System Max TelGM7772025-10-17
00883489002617RIGHTEST Blood Glucose Test Strip MaxGS7702025-10-17
00883489002631RIGHTEST Control Solution GC700GC7002025-10-17
00883489002556GEGE2002024-10-21
00883489002563GEGE2002024-10-21
00883489002518SMARTMETERGM2912024-01-18
00883489002525SMARTMETERGM2912024-01-18
00883489002495SMARTMETERGC5502023-12-15
00883489002501SMARTMETERGC5502023-12-15
00883489001290RIGHTESTGD5002023-07-03
00883489001313GEGD5002023-07-03
00883489001306RIGHTESTGD5002023-07-03
00883489001320GEGD5002023-07-03
00883489002372ODMDiathrive+ Blood Glucose Monitoring System99GM280DR12020-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374668SoftBiochemistrySCC SOFT COMPUTERJQP2026-10-28
00810142374675SoftCytogeneticsSCC SOFT COMPUTERJQP2026-10-28
00810142374682SoftPathDxSCC SOFT COMPUTERJQP2026-10-28
00810142374699SoftFlowCytometrySCC SOFT COMPUTERJQP2026-10-28
00810142374705SoftHLASCC SOFT COMPUTERJQP2026-10-28
00810142374712SoftMolecularSCC SOFT COMPUTERJQP2026-10-28
00810142374729SoftGenomicsSCC SOFT COMPUTERJQP2026-10-28
00810142374736SoftTrackSCC SOFT COMPUTERJQP2026-10-28
00850070979375FondCircleFondCircle Inc.NBW2026-10-27
00850070979344FondCircleFondCircle Inc.NBW2026-10-26
00850070979351FondCircleFondCircle Inc.NBW2026-10-26
00850070979368FondCircleFondCircle Inc.NBW2026-10-26
00810142374941SoftBiochemistrySCC SOFT COMPUTERJQP2026-10-16
00810142374958SoftCytogeneticsSCC SOFT COMPUTERJQP2026-10-16
00810142374965SoftPathDxSCC SOFT COMPUTERJQP2026-10-16
00810142374972SoftFlowCytometrySCC SOFT COMPUTERJQP2026-10-16
00810142374989SoftHLASCC SOFT COMPUTERJQP2026-10-16
00810142374996SoftMolecularSCC SOFT COMPUTERJQP2026-10-16
00810142375009SoftGenomicsSCC SOFT COMPUTERJQP2026-10-16
00810142375016SoftTrackSCC SOFT COMPUTERJQP2026-10-16
00810142374071SoftTotalQCSCC SOFT COMPUTERJQP2026-10-07
00810142373456SoftLabSCC SOFT COMPUTERJQP2026-09-29
00810142373463SoftMicSCC SOFT COMPUTERJQP2026-09-29
B236CATL202520Clinisys AtlasCliniSys, IncJQP2026-09-29
00380740225384AlinIQABBOTT SRLJQP2026-09-28
00810142374378SoftBiochemistrySCC SOFT COMPUTERJQP2026-08-26
00810142374385SoftCytogeneticsSCC SOFT COMPUTERJQP2026-08-26
00810142374392SoftPathDxSCC SOFT COMPUTERJQP2026-08-26
00810142374408SoftFlowCytometrySCC SOFT COMPUTERJQP2026-08-26
00810142374415SoftHLASCC SOFT COMPUTERJQP2026-08-26