| Primary Device ID | 20613994130383 |
| NIH Device Record Key | 5837fa14-dcdf-471f-ac4e-ec3bfef66aa2 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 550-13 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 30 |
| 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 | 00613994130389 [Unit of Use] |
| GS1 | 20613994130383 [Primary] |
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| 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 | 2016-07-17 |
| 00199150003624 - NA | 2025-04-11 CUSTOM PACK BB5723R37 CHR LINF |
| 00199150003631 - NA | 2025-04-11 CUSTOM PACK BB11Y69R2 SATELLITE |
| 00199150003969 - NA | 2025-04-11 CUSTOM PACK BB10Z37R8 PEDS PACK |
| 00199150003976 - NA | 2025-04-11 CUSTOM PACK BB11R40R1 TRANS PORT |
| 00199150004041 - NA | 2025-04-11 CUSTOM PACK BB8D33R18 PUMP PK |
| 20199150004069 - NA | 2025-04-11 CUSTOM PACK BB7U92R3 5PK BRIDGE PK |
| 20199150004083 - NA | 2025-04-11 CUSTOM PACK BB10V11R1 5PK EXTENSION LIN |
| 20199150004120 - NA | 2025-04-11 CUSTOM PACK BB9R13R13 4PK PLEG PACK |