Guardian™ Sensor (3)

GUDID 00763000140779

SENSOR MMT-7020B GS3 1PK 2L US

MEDTRONIC MINIMED, INC.

Percutaneous glucose monitoring system

• Primary Device ID: 00763000140779
• NIH Device Record Key: 2bd5fefa-9f35-46d4-ad22-6eb40b500650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian™ Sensor (3)
• Version Model Number: MMT-7020B
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000140779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160017

FDA Product Code

• OZO: Automated insulin dosing , threshold suspend

Sterilization

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

Device Entry Metadata

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

On-Brand Devices [Guardian™ Sensor (3)]

• 00763000157616: SENSOR MMT-7020B GS3 1PK 2L US
• 00763000140779: SENSOR MMT-7020B GS3 1PK 2L US
• 20763000157603: SENSOR MMT-7020A GS3 5PK 2L US
• 20763000140940: SENSOR MMT-7020A GS3 5PK 2L US
• 20763000179629: SENSOR MMT-7020GA GS3 5PK US GC
• 00763000179601: SENSOR MMT-7020GA GS3 5PK US GC
• 00763000337001: SENSOR MMT-7020A GS3 5PK 2L US
• 00763000337049: SENSOR MMT-7020B GS3 1PK 2L US
• 00763000336998: SENSOR MMT-7020LB GS3 1PK US
• 00763000336981: SENSOR MMT-7020LA GS3 5PK US
• 00763000358440: SENSOR MMT-7020PLA GS3 5PK 2L US
• 00763000455651: SENSOR MMT-7020GA GS3 5PK 2L US
• 00763000455682: SENSOR MMT-7020PLA GS3 5PK 2L US
• 00763000455668: SENSOR MMT-7020A GS3 5PK 2L US
• 00763000455675: SENSOR MMT-7020B GS3 1PK 2L US
• 00763000516239: SENSOR MMT-7020MLA GS3 5PK US
• 20763000578798: SENSOR MMT-7020A GS3 5PK US
• 00763000578848: SENSOR MMT-7020B GS3 1PK US
• 00763000578800: SENSOR MMT-7020LA GS3 5PK US