Care Essentials Pty, Ltd.
Medical device manufacturer in North Geelong, AU.
4510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K232502 | Cocoon Convective Warming System, Model CWS7000DWJ · Traditional | 02/21/2024SE |
| K213907 | CareGUARD Sterilization WrapFRG · Traditional | 03/14/2022SE |
| K181671 | Cocoon Convective Warming SystemDWJ · Special | 05/02/2019SE |
| K140635 | Cocoon Convective Warming SystemDWJ · Traditional | 07/25/2014SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0987-2020 Class II | Cocoon Convective Warming System, Product Code: CWS5000 (110V).Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper… | 01/07/2020Terminated |
| Z-0986-2020 Class II | Cocoon Convective Warming System, Product Code: CWS4000 (110V).Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper… | 01/07/2020Terminated |