GUDID 00613994384119

PROG 37642 PATIENT DBS ACTIVA US MKT DOM

MEDTRONIC, INC.

Neuromuscular electrical stimulation system programmer

• Primary Device ID: 00613994384119
• NIH Device Record Key: fa62eb4c-8875-48fc-93ac-6d6305c36253
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 37642
• 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

• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994384119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

FDA Product Code

• MFR: Stimulator, brain, implanted, for behavior modification
• MRU: implanted subcortical electrical Stimulator (motor disorders)

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

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