SYNCHROMED®II
GUDID 00643169984219
PUMP 8637-20 SYNCHROMED II 20ML DLC US
MEDTRONIC, INC.
Implantable intrathecal infusion pump, programmable| Primary Device ID | 00643169984219 |
| NIH Device Record Key | b6b39591-2e8c-4e69-9335-b4eb318a6eaf |
| 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 | 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 | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
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 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| 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 | 00643169984219 [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.