FDA.reportPublic FDA data

Gmate® Control Solution Level 2

Primary DI
08809301162019
Brand
Gmate® Control Solution Level 2
Company
PHILOSYS Co., Ltd
Model
PC-002
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113636000BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)Philosys Co., Ltd.2013-03-08CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809301162019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809301162019088093011620198809301162019

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
Expiration date on label
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

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00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
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