| Primary Device ID | 04037692009925 |
| NIH Device Record Key | 18ef3248-828c-4f6b-8162-c4932b5d3c7c |
| Commercial Distribution Discontinuation | 2017-02-16 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | QUADROX-iD Adult, SOFTLINE Coating |
| Catalog Number | 70106.7840 |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +49072229320 |
| info.cp@maquet.com |
| Total Volume | 215 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04037692009925 [Primary] |
| DTR | HEAT-EXCHANGER, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2015-12-15 |
| 04037691645148 - NA | 2024-12-11 CARDIOHELP Emergency Drive Holder for rail |
| 04037691645155 - NA | 2024-12-11 CARDIOHELP Emergency Drive Holder for mast |
| 04037691720791 - NA | 2024-12-11 CARDIOHELP Holder for mast |
| 04037691002583 - NA | 2024-09-30 |
| 04037691349190 - BMU 40 | 2024-09-30 |
| 04037691349206 - BMU 40 | 2024-09-30 |
| 04037691349213 - BMU 40 | 2024-09-30 |
| 04037691349220 - BMU 40 | 2024-09-30 |