Guardian ™ Sensor (3)

GUDID 20763000017556

SENSOR MMT-7020A ENLITE3 5PK 2L PR

MEDTRONIC MINIMED, INC.

Percutaneous glucose monitoring system sensor

• Primary Device ID: 20763000017556
• NIH Device Record Key: 4d674291-6929-465d-a461-9e24141876e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian ™ Sensor (3)
• Version Model Number: MMT-7020A
• 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
• 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
• 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 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000017552 [Primary]
GS1	20763000017556 [Package]; Contains: 00763000017552; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150001

FDA Product Code

• OZP: Automated insulin dosing device system, single hormonal control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-07
• Device Publish Date: 2018-01-02

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

• 00643169704060: SENSOR MMT-7020B ENLITE3 2L US
• 00763000117030: SENSOR MMT-7020B 1PK 2L US
• 00763000017569: SENSOR MMT-7020B ENLITE3 2L PR
• 20763000017556: SENSOR MMT-7020A ENLITE3 5PK 2L PR
• 20763000118864: SENSOR MMT-7020A 5PK 2L US
• 20643169704057: SENSOR MMT-7020A ENLITE3 5PK 2L US