| Device Type ID | 2649 |
| Device Name | Device, Pasteurization, Hot Water |
| Regulation Description | Medical Washer. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6991 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LDS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2649 |
| Device | Device, Pasteurization, Hot Water |
| Product Code | LDS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Washer. |
| CFR Regulation Number | 880.6991 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cenorin, LLC | II | Jun-26-2018 |
| 2 | Cenorin, LLC | II | Jul-06-2014 |
| 3 | Cenorin, LLC | II | Jun-06-2014 |
| 4 | Natus Medical Incorporated | II | Jun-01-2016 |