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Curo L5

Primary DI
00850006113064
Brand
Curo L5
Company
KPI HEALTHCARE, INC.
Model
Curo L5
Device description
CURO L5 Glucose Strip
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850006113064PrimaryGS10
00850006113057Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006113064008500061130648500061130640850006113064
00850006113057008500061130578500061130570850006113057

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
50
Lot or batch
true
Expiration 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
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
00860394001263CURO G6 Glucose MeterCURO G6 Glucose Meter2019-04-26
00860394001270Curo A1c AnalyzerCuro A1c Analyzer2019-04-26
00860394001294CURO Glucose StripsCURO Glucose Strips2019-04-26

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