SynchroMed® II
GUDID 00643169530119
PUMP 8637-20 SYNCHMED II 20ML DLC MOTOR
MEDTRONIC, INC.
General-purpose implantable infusion pump, programmable| Primary Device ID | 00643169530119 |
| NIH Device Record Key | 830a2a07-444c-496f-9c95-12befde36931 |
| 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
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 |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *No Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *No Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *No Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *No Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *No Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *No Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 *No 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 | 00643169530119 [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 | 2017-07-17 |
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 |
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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