CLOTtrac®
GUDID 20613994923343
BOXED 550-12 CLOTTRAC HTC CONTROL
MEDTRONIC, INC.
Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control| 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 |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994923349 [Unit of Use] |
| GS1 | 20613994923343 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042175
FDA Product Code
| JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-18 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000951825 - NA | 2024-05-31 CUSTOM PACK SSBB12G88R STERILE SMPL |
| 00763000953423 - NA | 2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK |
| 00763000953614 - NA | 2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN |
| 00763000953621 - NA | 2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC |
| 00763000953638 - NA | 2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP |
| 00763000953645 - NA | 2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP |
| 20763000953663 - NA | 2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL |
| 00763000953676 - NA | 2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK |
Trademark Results [CLOTtrac]
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 |
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