NIF — Catheter, Hemodialysis, Triple Lumen, Implanted Class II
FDA product code NIF covers "Catheter, Hemodialysis, Triple Lumen, Implanted", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants.
Classification Details
- Product Code
- NIF
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion.