| Primary Device ID | 18051160302816 |
| NIH Device Record Key | 8791286e-2287-4a29-a888-378810d902b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum SuperPAC Tubing set - SP07C-AA |
| Version Model Number | SP07C-AA |
| 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 | false |
| 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 | 18051160302816 [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 |
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| 18051160302755 - Quantum SuperPAC Tubing set - SP07C-DA | 2024-08-20 |
| 18051160302816 - Quantum SuperPAC Tubing set - SP07C-AA | 2024-08-20 |
| 18051160302816 - Quantum SuperPAC Tubing set - SP07C-AA | 2024-08-20 |