mySentry™

GUDID 00613994545527

REPEATER MMT-9102NAR MYSNTRY SIG EN RPL

MEDTRONIC MINIMED, INC.

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00613994545527
• NIH Device Record Key: 1f3e2f36-a58b-4d0f-b47e-3f6ddf76f3d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mySentry™
• Version Model Number: MMT-9102NAR
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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(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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994545527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980022

FDA Product Code

• MDS: Sensor, glucose, invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2014-09-23

On-Brand Devices [mySentry™]

• 00613994906052: MONITOR MMT-9101 MYSNTRY1 V1.1 EN
• 00613994545541: POWER SUPPLY MMT-9103NAR MYSENTRY EN RPL
• 00613994545527: REPEATER MMT-9102NAR MYSNTRY SIG EN RPL
• 00613994545503: MONITOR MMT-9101NAR MYSENTRY GLC EN RPL