FreeStyle CoPilot 71137

GUDID 30357599000173

FreeStyle CoPilot Health Management System

ABBOTT DIABETES CARE INC

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• 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

• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
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• Phone: +1(888)522-5226
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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

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• 30357599835003 - FreeStyle Libre 2 Plus: 2023-10-13 FreeStyle Libre 2 Plus Sensor
• 30357599836000 - FreeStyle Libre 2 Plus: 2023-10-13 FreeStyle Libre 2 Plus Sensor Not For Retail Sale
• 57599-0820-00 - FreeStyle Libre 3: 2023-08-04 FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
• 00357599816001 - FreeStyle Libre 3 App: 2022-08-03 FreeStyle Libre 3 Android App US
• 00357599817008 - FreeStyle Libre 3 App: 2022-07-13 FreeStyle Libre 3 iOS App US
• 30357599818006 - FreeStyle Libre 3: 2022-07-01 FreeStyle Libre 3 Sensor Kit US
• 30357599819003 - FreeStyle Libre 3: 2022-07-01 FreeStyle Libre 3 Sensor Kit NFRS