GUDID 00763000875725

COMMUNICATOR 8880T2-RFB CLN CTM RFRB GRC

MEDTRONIC, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000875725
• NIH Device Record Key: 35b7a22b-9fef-4b0c-9239-6f36036297f4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8880T2-RFB
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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
• 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 -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000875725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

FDA Product Code

• LKK: Pump, infusion, implanted, programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-12-09

Devices Manufactured by MEDTRONIC, INC.

• 20763000982946 - NA: 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD
• 00763000984007 - NA: 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
• 00763000984021 - NA: 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
• 00763000984151 - NA: 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
• 00763000984168 - NA: 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
• 00763000984175 - NA: 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK
• 00763000180010 - Sprint Quattro Secure S™: 2024-11-12 LEAD 693552 SPRINT US RCMCRD
• 00763000180027 - Sprint Quattro Secure S™: 2024-11-12 LEAD 693575 SPRINT US RCMCRD