FreeStyle Libre 3

GUDID 00357599821005

ABBOTT DIABETES CARE INC

Percutaneous interstitial fluid glucose monitoring system, electrochemical

• Primary Device ID: 00357599821005
• NIH Device Record Key: 0d456be5-41d5-4810-829c-5c76185c2130
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Libre 3
• Version Model Number: 72078
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599821005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223435

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-28
• Device Publish Date: 2025-07-18

On-Brand Devices [FreeStyle Libre 3]

• 30357599819003: FreeStyle Libre 3 Sensor Kit NFRS
• 30357599818006: FreeStyle Libre 3 Sensor Kit US
• 57599-0820-00: FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
• 30357599842001: FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
• 30357599821013: FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
• 00357599821005: 72078
• 30357599842018: FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
• 30357599820016: FreeStyle Libre 3 Continuous Glucose Monitoring System Reader