| Primary Device ID | 04058863080383 |
| NIH Device Record Key | 5e001841-a422-4a15-8f1f-bb6b0735a37d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HLS Set |
| Version Model Number | BEQ-HLS 7050 USA |
| Catalog Number | 701069078 |
| 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 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 600 Milliliter |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04058863080383 [Primary] |
| DTZ | Oxygenator, 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 |
| 04058863080383 | HLS Set Advanced 7.0, Adult, BIOLINE Coating |
| 04058863078861 | HIT Set Advanced 7.0, Adult, SOFTLINE Coating |
| 04058863076355 | HLS Set Advanced 5.0, Small Adult, BIOLINE Coating |
| 04037691588285 | HKH 8870 Holder for priming bag |