SYNCHROMED®II
GUDID 00763000422608
PUMP 8637-20 SM II 20ML EMAN SYMBL GRC
MEDTRONIC, INC.
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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