SYNCHROMED®II
GUDID 00763000422608
PUMP 8637-20 SM II 20ML EMAN SYMBL GRC
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| Primary Device ID | 00763000422608 |
| NIH Device Record Key | f0901868-7337-4e19-b89b-143813388fbf |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from magnets |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000422608 [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 | 2024-04-03 |
| Device Publish Date | 2021-04-11 |
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 |
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