FDA.reportPublic FDA data

CURO G6 Glucose Meter

Primary DI
00860394001263
Brand
CURO G6 Glucose Meter
Company
KPI HEALTHCARE, INC.
Model
CURO G6 Glucose Meter
Device description
CURO G6 Glucose Meter
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132966000GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMInfopia Co, Ltd.2013-12-05NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860394001263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860394001263008603940012638603940012630860394001263

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump/interstitial glucose monitoring systemAn assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
087243403
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006113026CURO A1cCURO A1c2019-04-26
00850006113033CURO A1cCURO A1c2019-04-26
00850006113040CURO A1cCURO A1c2019-04-26
00850006113064Curo L5Curo L52019-04-26
00860394001225CURO L5CURO L5 CURO L52019-04-26
00860394001232CURO B3CURO B32019-04-26
00860394001249CURO G6s Smart Glucose MeterCURO G6s Smart Glucose Meter2019-04-26
00860394001256CURO L5 Total Cholesterol StripsCURO L5 Total Cholesterol Strips2019-04-26
00860394001270Curo A1c AnalyzerCuro A1c Analyzer2019-04-26
00860394001294CURO Glucose StripsCURO Glucose Strips2019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
00850044118250iHealthiHealth Labs Inc.LFR2023-08-30
00850044118267iHealthiHealth Labs Inc.LFR2023-08-30
00850044118205iHealthiHealth Labs Inc.LFR2023-08-24
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
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
08718734960584Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960607Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960621Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08718734960645Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11