FDA.reportPublic FDA data

Gmate® STEP Blood Glucose Monitoring System

Primary DI
08809301160121
Brand
Gmate® STEP Blood Glucose Monitoring System
Company
PHILOSYS Co., Ltd
Model
PG-201
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
K141656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141656000GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEMPhilosys, Inc.2015-10-02NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809301160121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809301160121088093011601218809301160121

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
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
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11