SYNCHROMED® II

GUDID 00643169630512

PUMP 8637-40 SYNCHMED II 40ML EMAN SYMBL

MEDTRONIC, INC.

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