SYNCHROMED® II

GUDID 00643169508156

PUMP 8637-40 SYNCHMED II 40ML POTTED FTS

MEDTRONIC, INC.

General-purpose implantable infusion pump, programmable

• Primary Device ID: 00643169508156
• NIH Device Record Key: b338013c-135d-4ddf-b858-4bd4b858efd6
• 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
• 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 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
• 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169508156 [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