Guardian™ Link

GUDID 00763000047672

STARTKIT MMT-7777NA GRDNLNK 1PRESJADE US

MEDTRONIC MINIMED, INC.

Percutaneous glucose monitoring system Percutaneous glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical

• Primary Device ID: 00763000047672
• NIH Device Record Key: 6c55e276-3814-4fe0-8423-ca9327eb10b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian™ Link
• Version Model Number: MMT-7777NA
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000047672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150001

FDA Product Code

• OZO: Artificial pancreas device system, threshold suspend

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-12

On-Brand Devices [Guardian™ Link]

• 00643169864672: XMTR MMT-7763NA GST3A2 21L
• 00643169800403: STARTER KIT MMT-7777NA GRDN LNK 1PRES US
• 00763000047672: STARTKIT MMT-7777NA GRDNLNK 1PRESJADE US
• 00763000047665: REPL KIT MMT-7763NA GST3A2 ROUTE JADE