| Device Type ID | 2798 |
| Device Name | Warmer, Irrigation Solution |
| Regulation Description | Powered Heating Unit. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | General Hospital |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.5950 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LHC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2798 |
| Device | Warmer, Irrigation Solution |
| Product Code | LHC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Powered Heating Unit. |
| CFR Regulation Number | 890.5950 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ECOLAB INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ECOLAB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GETINGE SOURCING, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Hole In Material | 34 |
Crack | 4 |
Material Puncture / Hole | 3 |
Device Issue | 2 |
Material Fragmentation | 1 |
Inadequate Or Insufficient Training | 1 |
Leak / Splash | 1 |
Excessive Heating | 1 |
Fluid Leak | 1 |
Overheating Of Device | 1 |
Temperature Problem | 1 |
Insufficient Information | 1 |
Strikethrough | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Fracture | 1 |
| Total Device Problems | 56 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ecolab Inc | II | Sep-18-2015 |
| 2 | Resource Optimization & Innovation Llc | II | Oct-30-2015 |
| 3 | Smiths Medical ASD, Inc. | II | Jan-26-2017 |