FDA.reportPublic FDA data

Gmate® Origin Blood Glucose Monitoring System

Primary DI
08809301160206
Brand
Gmate® Origin Blood Glucose Monitoring System
Company
PHILOSYS Co., Ltd
Model
PG-310
Published
2017-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151658000Gmate Origin Blood Glucose Monitoring SystemPhilosys, Inc.2015-12-01NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809301160206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809301160206088093011602068809301160206

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA 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 for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Regulatory Flags#

DUNS number
690184887
Device count
1
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809301161760Pip Blood Glucose Test StripsPS-0042020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPG-3102020-09-11
08809301161777Pip Blood Glucose Test StripsPS-0042020-09-11
08809301162194Pip Control Solution LowPC001-US2020-09-11
08809301162200Pip Control Solution NormalPC002-US2020-09-11
08809301162217Pip Control Solution HighPC003-US2020-09-11
08809301160411Gmate Smart Blood Glucose Monitoring SystemPG-1012018-09-17
08809301168011GlucoTrack Blood Glucose Test StripsGT-S012018-08-16
08809301168042GlucoTrack Blood Glucose Test StripsGT-S012018-08-16
08809301168059GlucoTrack Solution Level 1GT-C012018-08-16
08809301168066GlucoTrack Solution Level 2GT-C022018-08-16
08809301168073GlucoTrack Solution Level 3GT-C032018-08-16
08809301168080GlucoTrack Voice Blood Glucose Monitoring SystemGT-3012018-08-16
08809301168097GlucoTrack VOICE Blood Glucose Monitoring SystemGT-3012018-08-16
08809301168103GlucoTrack VOICE Blood Glucose Monitoring SystemGT-3012018-08-16
08809301168110GlucoTrack SMART Blood Glucose Monitoring SystemGT-1012018-08-16
08809301168127GlucoTrack SMART Blood Glucose Monitoring SystemGT-1012018-08-16
08809301168134GlucoTrack SMART Blood Glucose Monitoring SystemGT-1012018-08-16
08809301160015Gmate® mini Blood Glucose Monitoring SystemPG-2002017-06-06
08809301160022Gmate® STEP Blood Glucose Monitoring SystemPG-2012017-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
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
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
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05700699461131SC90Radiometer Medical ApSCGA2026-07-09
05700699461605SC90Radiometer Medical ApSCGA2026-07-09
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08