Libre App 78746-01

GUDID 00357599841003

Libre IOS App US

ABBOTT DIABETES CARE INC

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

• Primary Device ID: 00357599841003
• NIH Device Record Key: b570d3cc-19c3-4f7e-b966-8b071b5829a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Libre App
• Version Model Number: 78746-01
• Catalog Number: 78746-01
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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: 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
• 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	00357599841003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233537

FDA Product Code

• QLG: Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems

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: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [Libre App]

• 00357599841003: Libre IOS App US
• 00357599840006: Libre Android App US