| 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 |
| 20199150000030 - NA | 2025-03-04 CUSTOM PACK BB6Q05R1 5PK 3/8 TUB |
| 20763000999449 - NA | 2025-03-04 CUSTOM PACK BB6R53R1 20PK 3/8 C/WLL |
| 20763000999463 - NA | 2025-03-04 CUSTOM PACK BB2T40R3 2PK TABLE LINE |
| 00763000999476 - NA | 2025-03-04 CUSTOM PACK BB12G75R2 WM ACC |
| 20763000999494 - NA | 2025-03-04 CUSTOM PACK BB8Q15R1 10PK 1/2 VENOUS |
| 00763000999506 - NA | 2025-03-04 CUSTOM PACK BB10R64R13 CAMC PERF |
| 00763000582890 - Avalus™ 7400S | 2025-03-03 SIZERS 7400S AVALUS CEM GLOBAL |
| 00763000582906 - Valve Handle 7420 | 2025-03-03 HANDLE 7420 VLV HNDLE 234MM CEM GLOBAL |