Primary Device ID | 00613994779229 |
NIH Device Record Key | 9698bdb3-661b-4900-919f-2d130abf8d75 |
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 |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Total Volume | 20 Milliliter |
Total Volume | 20 Milliliter |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00613994779229 [Primary] |
LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-04-27 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYNCHROMED 73726779 1551794 Live/Registered |
MEDTRONIC, INC. 1988-05-06 |