SYNCHROMED®II
GUDID 00643169984226
PUMP 8637-40 SYNCHROMED II 40ML DLC US
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 | 00643169984226 |
| NIH Device Record Key | 78f341db-e6fb-4cee-8d20-359b6e6b65ea |
| 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 | MR Conditional |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
| Total Volume | 40 Milliliter |
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 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| 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 | 00643169984226 [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 | 2019-08-08 |
| Device Publish Date | 2018-07-09 |
On-Brand Devices [SYNCHROMED®II]
| 00643169984226 | PUMP 8637-40 SYNCHROMED II 40ML DLC US |
| 00643169984219 | PUMP 8637-20 SYNCHROMED II 20ML DLC US |
| 00763000422615 | PUMP 8637-40 SM II 40ML EMAN SYMBL GRC |
| 00763000422608 | PUMP 8637-20 SM II 20ML EMAN SYMBL GRC |
Trademark Results [SYNCHROMED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNCHROMED 73726779 1551794 Live/Registered |
MEDTRONIC, INC. 1988-05-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.