Central Venous Catheter Dressing Change Kit
The Central Venous Catheter Dressing Change Kit is a general hospital convenience kit established in accordance with FDA guidance, providing the components necessary for changing the dressing at the insertion site of a central venous catheter to reduce the risk of catheter-related infections. It falls under the General Hospital medical specialty and is classified as a Class 2 device under regulation 880.5200, requiring 510(k) premarket notification. Standardized dressing change kits support consistent aseptic technique in catheter maintenance. It is not an implant and is not life-sustaining.
Research product code PEZ 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
- PEZ
- Device Class
- FDA class 2
- Regulation Number
- 880.5200
- 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 www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.