| Primary Device ID | 04058863299983 |
| NIH Device Record Key | aa4ea870-1082-4592-8fb2-08b274bc7bbf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quadrox-iD |
| Version Model Number | BEQ-HMOD30000-USA |
| Catalog Number | 701070397 |
| Company DUNS | 316153865 |
| Company Name | Maquet Cardiopulmonary AG |
| 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 | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04058863154435 [Primary] |
| GS1 | 04058863299983 [Package] Contains: 04058863154435 Package: [4 Units] In Commercial Distribution |
| DTR | Heat-Exchanger, 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 | 2021-08-06 |
| Device Publish Date | 2021-07-29 |
| 04058863019024 | QUADROX-iD Adult Diffusion Membrane Oxygenator, BIOLINE coated, without a filter, with a screw |
| 04058863019000 | QUADROX-iD Adult Diffusion Membrane Oxygenator, without Filter, NON-COATED, with a screw connec |
| 04037691741161 | QUADROX-iD Adult, without filter, SOFTLINE coating, non-sterilized, semi-finished Product. |
| 04037691739335 | QUADROX-iD Adult, without filter, BIOLINE Coating, non-sterile, semi-finished product. |
| 04058863299983 | QUADROX-iD Pediatric with BIOLINE Coating |
| 04037691576640 | 016061 Holder arm |