Vacuum Powered Body Fluid Collection Kit
The Vacuum Powered Body Fluid Collection Kit is a convenience kit containing components that use vacuum suction to collect body fluids (such as wound drainage or surgical site fluids) for clinical management or disposal in surgical settings. Classified as FDA Class 2 under regulation 21 CFR 878.4780 within the General, Plastic Surgery medical specialty, it falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are satisfied. The product code is OJR. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OJR
- Device Class
- FDA class 2
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- 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 www.fda.gov/cdrh/ode/convkit.html. 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 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.