Primary Device ID | 20613994923343 |
NIH Device Record Key | f6f53dec-291a-4218-89e5-b3c9aee929f3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CLOTtrac® |
Version Model Number | 550-12 |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
Device Count | 15 |
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 | 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 | false |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C. |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00613994923349 [Unit of Use] |
GS1 | 20613994923343 [Primary] |
JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-06-18 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLOTTRAC 85769854 4328450 Live/Registered |
Medtronic, Inc. 2012-11-02 |
CLOTTRAC 74059073 1640189 Dead/Cancelled |
HemoTec, Inc. 1990-05-15 |