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CURO L5

Primary DI
00860394001225
Brand
CURO L5
Company
KPI HEALTHCARE, INC.
Model
CURO L5 CURO L5
Device description
CURO L5 Cholesterol and Glucose measuring system
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
CGAGlucose Oxidase, Glucose
CHHEnzymatic Esterase--Oxidase, Cholesterol
JGYColorimetric Method, Triglycerides
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LBRLdl & Vldl Precipitation, Hdl
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1
JGYColorimetric Method, TriglyceridesClinical Chemistry1
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130295000LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.Infopia Co, Ltd.2013-06-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860394001225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860394001225008603940012258603940012250860394001225

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check analyserAn electrically-powered device intended to be used exclusively at the point-of-care by medical professionals to spot-check measure and record multiple physiological and biological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure and haemoglobin oxygen saturation (SpO2), blood glucose, blood cholesterol]. It consists of a portable electronic unit intended to be used with noninvasive devices [not included] (e.g., blood pressure cuff, ECG leads) and rapid test strips; measured data is typically wirelessly sent to a phone/tablet device with software for viewing.

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
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
00860394001263CURO G6 Glucose MeterCURO G6 Glucose Meter2019-04-26
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
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850075956777Refractrol SP NormalLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956784Refractrol SP 9.0 HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956807Refractrol SP HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075957286Refractrol SP LowLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956791Refractrol SP 6.0 LowLgc Clinical Diagnostics, Inc.JJX2026-07-28
10758750035847VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-07-21
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14