Vomitus Clean-Up Kit
The Vomitus Clean-Up Kit is a convenience kit designed to assist healthcare personnel in safely cleaning up vomitus in clinical environments, packaging the necessary supplies for infection control and cleanup. It is classified as a Class 1 device under regulation 880.6890, subject to general controls only, and per the FDA's May 1997 convenience kits guidance, this kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all criteria in the guidance. The product code is PXM, and it falls within the General Hospital (HO) medical specialty. It is not an implant and is not life-sustaining.
Research product code PXM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PXM
- Device Class
- FDA class 1
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.