CURO L5

GUDID 00860394001225

CURO L5 Cholesterol and Glucose measuring system

KPI HEALTHCARE, INC.

Multiple physiological parameter spot-check analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser Multiple physiological parameter spot-check system analyser

• Primary Device ID: 00860394001225
• NIH Device Record Key: 032176df-3efc-4201-8480-6a77d8be77cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURO L5
• Version Model Number: CURO L5 CURO L5
• Company DUNS: 087243403
• Company Name: KPI HEALTHCARE, INC.
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00860394001225 [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

On-Brand Devices [CURO L5]

• 00860394001225: CURO L5 Cholesterol and Glucose measuring system
• 00850006113064: CURO L5 Glucose Strip