| Primary Device ID | 04050674082532 |
| NIH Device Record Key | 4f59cd93-98e5-4987-866d-39ecfd7fe291 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROTIXA 500 RS |
| Version Model Number | ROTIXA 500, Standard, Heat/Cool |
| Catalog Number | 4950-58 |
| Company DUNS | 316403245 |
| Company Name | Andreas Hettich GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04050674082532 [Primary] |
| QBV | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-10 |
| Device Publish Date | 2021-09-02 |
| 04050674082532 | Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate |
| 04050674076333 | Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate |
| 04050674076326 | Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate |
| 04050674076302 | Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate |
| 04050674075572 | Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate |