Guardian™ Connect App

GUDID 00763000186333

SFTWR CSS7200 GRDN MBL APP IOS V3.2.3

MEDTRONIC MINIMED, INC.

Patient health record information system application software Patient health record information system application software

• Primary Device ID: 00763000186333
• NIH Device Record Key: da43e0b0-913c-445e-9649-a4cdab4f75cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian™ Connect App
• Version Model Number: CSS7200
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000186333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160007

FDA Product Code

• MDS: Sensor, glucose, invasive

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: 2018-10-24
• Device Publish Date: 2018-09-23

On-Brand Devices [Guardian™ Connect App]

• 00763000186333: SFTWR CSS7200 GRDN MBL APP IOS V3.2.3
• 00763000158392: SFTWR CSS7200 GRDN IOS APP V3.2.1
• 00763000381103: SFTWR CSS7200 GRDN MBL IOS V 4.1.0
• 00763000381097: SFTWR CSS7201 GRDN MBL ANDROID V 4.1.0