| Primary Device ID | 18051160303202 |
| NIH Device Record Key | 1762664f-3cfd-4e25-8b6d-77990489705e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum SuperPAC Hybrid CPB |
| Version Model Number | SPC200A-D5 |
| Company DUNS | 436188505 |
| Company Name | SPECTRUM MEDICAL SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18051160303202 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-30 |
| Device Publish Date | 2025-09-22 |
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