| Primary Device ID | 38033178106048 |
| NIH Device Record Key | de0c424e-92d1-4f7d-86c7-82f44d62ff95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BRAT 2 |
| Version Model Number | BOWL PROCESSING SET - 135 ml |
| Company DUNS | 442126587 |
| Company Name | SORIN GROUP ITALIA SRL |
| 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 | false |
| 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 | 08033178106047 [Primary] |
| GS1 | 38033178106048 [Package] Contains: 08033178106047 Package: BOX [6 Units] In Commercial Distribution |
| CAC | APPARATUS, AUTOTRANSFUSION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-01-08 |
| Device Publish Date | 2015-07-06 |
| 38033178109728 | PROCEDURE SET (CYA)- 120 µm/250 ml |
| 38033178109711 | PROCEDURE SET (20 ft) - 30 µm/250 ml |
| 38033178106260 | RESERVOIR WITH OUTLET CLAMP 30 µm |
| 38033178106253 | RESERVOIR WITH OUTLET CLAMP 120 µm |
| 38033178106246 | STANDBY COLLECTION SET - 30 µm |
| 38033178106239 | STANDBY COLLECTION SET - 120 µm |
| 38033178106055 | BOWL PROCESSING SET - 250 ml |
| 38033178106048 | BOWL PROCESSING SET - 135 ml |
| 38033178106017 | PROCEDURE SET - 30 µm/250 ml |
| 38033178106000 | PROCEDURE SET - 120 µm/250 ml |
| 38033178105980 | PROCEDURE SET - 30 µm/135 ml |
| 38033178105973 | PROCEDURE SET - 120 µm/135 ml |