| Primary Device ID | 28051160302479 |
| NIH Device Record Key | d576fde4-5a17-4f39-9b7e-326b72af32a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIT Quantum SuperPAC Tubing Set - 160 |
| Version Model Number | SPC-160 |
| Company DUNS | 436188505 |
| Company Name | SPECTRUM MEDICAL SRL |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 28051160302479 [Primary] |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-20 |
| Device Publish Date | 2024-08-12 |
| 18051160302755 - Quantum SuperPAC Tubing set - SP07C-DA | 2024-08-20 |
| 18051160302816 - Quantum SuperPAC Tubing set - SP07C-AA | 2024-08-20 |
| 18051160302830 - Quantum SuperPAC Tubing set - SP08C-AA | 2024-08-20 |
| 18051160302847 - Quantum SuperPAC Tubing set - SP09C-DA | 2024-08-20 |
| 18051160302854 - Quantum SuperPAC Tubing set - SP09C-AA | 2024-08-20 |
| 28051160302462 - KIT Quantum SuperPAC Tubing Set - 200 | 2024-08-20 |
| 28051160302479 - KIT Quantum SuperPAC Tubing Set - 160 | 2024-08-20 |
| 28051160302479 - KIT Quantum SuperPAC Tubing Set - 160 | 2024-08-20 |
| 28051160302509 - KIT Quantum SuperPAC Tubing Set - 200R | 2024-08-20 |