Device Type ID | 2542 |
Device Name | Washer Of Body Waste Receptacles |
Regulation Description | Washers For Body Waste Receptacles. |
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) General Hospital Devices Branch (GHDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 880.6800 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FLH |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2542 |
Device | Washer Of Body Waste Receptacles |
Product Code | FLH |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Washers For Body Waste Receptacles. |
CFR Regulation Number | 880.6800 [🔎] |
Device Problems | |
---|---|
Device Emits Odor | 3 |
Off-Label Use | 1 |
Installation-Related Problem | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Fire | 1 |
Difficult To Open Or Close | 1 |
Total Device Problems | 8 |