FDA product code FII
System, Dialysate Delivery, Sealed
Gastroenterology, Urology·Class 2·21 CFR 876.5860·Life-sustaining
US regulatory classifications
- US Product Code (FDA)
- FIIView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 876.5860View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- Yes
- Third party review
- Not Eligible
Search keywords
Click to search for similar devices in our global database
About this record
System, Dialysate Delivery, Sealed is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.