N'VISION®

GUDID 00643169427037

SW 8870MMC01 NVISION INTSTM ENTERRA2 US

MEDTRONIC, INC.

Active-implantable-device communicator Active-implantable-device communicator Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer

• Primary Device ID: 00643169427037
• NIH Device Record Key: e4bd0293-0fec-4973-b006-39667369400d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N'VISION®
• Version Model Number: 8870MMC01
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169427037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H990014

FDA Product Code

• LNQ: intestinal Stimulator

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: 2014-09-29