SYNCHROMED® II

GUDID 00643169508149

PUMP 8637-20 SYNCHMED II 20ML POTTED FTS

MEDTRONIC, INC.

General-purpose implantable infusion pump, programmable General-purpose implantable infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable

• Primary Device ID: 00643169508149
• NIH Device Record Key: dd191649-93f1-4ebf-a672-c25fe6c62128
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNCHROMED® II
• Version Model Number: 8637-20
• 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: true
• Single Use: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169508149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860004

FDA Product Code

• LKK: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-27

On-Brand Devices [SYNCHROMED® II]

• 00643169630512: PUMP 8637-40 SYNCHMED II 40ML EMAN SYMBL
• 00643169630505: PUMP 8637-20 SYNCHMED II 20ML EMAN SYMBL
• 00643169530126: PUMP 8637-40 SYNCHMED II 40ML DLC MOTOR
• 00643169530119: PUMP 8637-20 SYNCHMED II 20ML DLC MOTOR
• 00643169508156: PUMP 8637-40 SYNCHMED II 40ML POTTED FTS
• 00643169508149: PUMP 8637-20 SYNCHMED II 20ML POTTED FTS
• 00763000634100: PUMP 8637-40 SM II 40ML EMAN SYMBL
• 00763000634094: PUMP 8637-20 SM II 20ML EMAN SYMBL