Primary Device ID | 00643169984530 |
NIH Device Record Key | de96dbc3-92d8-466a-b65c-daca57bdb857 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | CB9S74R |
Company DUNS | 006261481 |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
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 | |
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 |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169984530 [Primary] |
KFM | Pump, blood, cardiopulmonary bypass, non-roller type |
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 | 2017-04-02 |
00763000180010 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693552 SPRINT US RCMCRD |
00763000180027 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693575 SPRINT US RCMCRD |
00763000180034 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 6935100 SPRINT US RCMCRD |
00763000180041 - Sprint Quattro Secure S MRI™ SureScan™ | 2024-11-12 LEAD 693558 SPRINT MRI US RCMCRD |
00763000180058 - Sprint Quattro Secure S MRI™ SureScan™ | 2024-11-12 LEAD 693565 SPRINT MRI US RCMCRD |
00763000180119 - Sprint Quattro Secure S MRI™ SureScan™ | 2024-11-12 LEAD 6935M55 MRI US DF4 RCMCRD |
00763000180126 - Sprint Quattro Secure S MRI™ SureScan™ | 2024-11-12 LEAD 6935M62 MRI US DF4 RCMCRD |
00763000180133 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 6935M49 US DF4 RCMCRD |