FreeStyle CoPilot 71137

GUDID 30357599000173

FreeStyle CoPilot Health Management System

ABBOTT DIABETES CARE INC

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 30357599000173
• NIH Device Record Key: 32c525be-2f0c-438a-8e34-33b7c067e18a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle CoPilot
• Version Model Number: 71137
• Catalog Number: 71137
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: true

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599000172 [Primary]
GS1	30357599000173 [Package]; Contains: 00357599000172; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062770

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

Devices Manufactured by ABBOTT DIABETES CARE INC

• 00357599840006 - Libre App: 2024-12-25 Libre Android App US
• 00357599841003 - Libre App: 2024-12-25 Libre IOS App US
• 00357599852009 - Lingo: 2024-08-01 Lingo Glucose Biosensor
• 00357599843007 - FreeStyle Libre 3 Plus: 2024-07-24 FreeStyle Libre 3 PLUS Sensor NFRS
• 30357599844005 - FreeStyle Libre 3 Plus: 2024-07-24 FreeStyle Libre 3 PLUS Sensor
• 30357599843008 - FreeStyle Libre 3 Plus: 2024-07-24 FreeStyle Libre 3 PLUS Sensor NFRS
• 00357599848002 - Lingo: 2024-07-23 Lingo Glucose Biosensor
• 00357599849009 - Lingo: 2024-07-23 Lingo Biosensor iOS App US