SYNCHROMED ® II
GUDID 00643169100831
PUMP 8637-20 SYNCHMED II 20ML PF
MEDTRONIC, INC.
General-purpose implantable infusion pump, programmable| Primary Device ID | 00643169100831 |
| NIH Device Record Key | 67176e14-d851-4ae3-aea3-6fda864922b4 |
| 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 | Labeling does not contain MRI Safety Information |
| 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 *Keep away from Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
| Handling Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from Magnets |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169100831 [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 | 2016-04-27 |
On-Brand Devices [SYNCHROMED ® II]
| 00613994779229 | PUMP 8637-20 SM2 20ML EMAN US JUN BATRY |
| 00643169100831 | PUMP 8637-20 SYNCHMED II 20ML PF |
| 00643169100824 | PUMP 8637-40 SYNCHMED II 40ML PF |
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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