| Primary Device ID | 04037691727868 |
| NIH Device Record Key | e723e756-2918-452e-a786-79c0ff67cb99 |
| Commercial Distribution Discontinuation | 2020-02-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | QUADROX-iD Adult, SOFTLINE Coating |
| Catalog Number | 70105.3815 |
| 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 | 04037691727851 [Primary] |
| GS1 | 04037691727868 [Package] Contains: 04037691727851 Package: [4 Units] Discontinued: 2020-02-01 Not in Commercial Distribution |
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-02-03 |
| Device Publish Date | 2015-10-24 |
| 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 |
| 04037691349237 - BMU 40 | 2024-09-30 |
| 04037691349244 - BMU 40 | 2024-09-30 |
| 04037691456584 - NA | 2024-09-30 Wall holder for ambulance. Mandatory for ambulance transportation. |