CGMS® iPro™

GUDID 00613994345240

WAND MMT-7712 CGMS IPRO MAGNETIC EN REPL

MEDTRONIC MINIMED, INC.

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• Primary Device ID: 00613994345240
• NIH Device Record Key: 3106a16f-5121-42d7-a64a-b135e9d2f44c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CGMS® iPro™
• Version Model Number: MMT-7712
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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 -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994345240 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [CGMS® iPro™]

• 00613994711076: RCDR MMT-7709NA CGMS IPRO V1.2 EN RPL
• 00613994677952: SYSTEM MMT-7708NA CGMS IPRO V1.0 EN C2
• 00613994562456: SYSTEM MMT-7708NA CGMS IPRO V1.0 EN
• 00613994417992: RCDR MMT-7709NA CGMS IPRO V1.0 EN RPL
• 00613994345240: WAND MMT-7712 CGMS IPRO MAGNETIC EN REPL
• 00613994343604: SYSTEM MMT-7708NA CGMS IPRO V1.0 EN