SYNCHROMED® II

GUDID 00643169630512

PUMP 8637-40 SYNCHMED II 40ML EMAN SYMBL

MEDTRONIC, INC.

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: 00643169630512
• NIH Device Record Key: cb389b42-b0f2-43f0-bdfa-e9e2f92e793a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNCHROMED® II
• Version Model Number: 8637-40
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from magnets
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169630512 [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: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-08-17

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