CURO L5 Total Cholesterol Strips

GUDID 00860394001256

Total Cholesterol Strips

KPI HEALTHCARE, INC.

Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use Glucose/ketone/lipid monitoring system IVD, home-use

• Primary Device ID: 00860394001256
• NIH Device Record Key: 3bd9e660-1303-4115-8589-7ce543467690
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURO L5 Total Cholesterol Strips
• Version Model Number: CURO L5 Total Cholesterol Strips
• Company DUNS: 087243403
• Company Name: KPI HEALTHCARE, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860394001218 [Unit of Use]
GS1	00860394001256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130295

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2019-04-26

Devices Manufactured by KPI HEALTHCARE, INC.

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• 00850006113064 - Curo L5: 2019-08-09 CURO L5 Glucose Strip
• 00860394001225 - CURO L5: 2019-08-09 CURO L5 Cholesterol and Glucose measuring system
• 00860394001232 - CURO B3: 2019-08-09 CURO B3 Blood Pressure Monitor
• 00860394001249 - CURO G6s Smart Glucose Meter: 2019-08-09 CURO G6s Smart Glucose Meter
• 00860394001256 - CURO L5 Total Cholesterol Strips: 2019-08-09Total Cholesterol Strips
• 00860394001256 - CURO L5 Total Cholesterol Strips: 2019-08-09 Total Cholesterol Strips