Dialysis Administration Kit
The Dialysis Administration Kit is a gastrointestinal and urology convenience kit established in accordance with FDA guidance to provide a collection of components used in the administration of dialysis procedures. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.5820, requiring 510(k) premarket notification. These kits consolidate dialysis-related supplies to facilitate efficient and standardized procedure setup. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PEV
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- 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 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.