CURO A1c

GUDID 00850006113033

Curo A1c Test Cartridge

KPI HEALTHCARE, INC.

Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system

• Primary Device ID: 00850006113033
• NIH Device Record Key: 20af46b1-703d-41ce-b8b8-fd1f9ad9b32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURO A1c
• Version Model Number: CURO A1c
• 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: false
• 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	00850006113002 [Unit of Use]
GS1	00850006113033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082275

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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 A1c]

• 00850006113040: CURO A1c Daily Check Cartridge
• 00850006113033: Curo A1c Test Cartridge
• 00850006113026: CURO A1c Monthly Check Cartridge