Product code NIE
- Device name
- Catheter, Hemodialysis, Triple Lumen, Non-Implanted
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5540
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
- Source
- FDA openFDA device classification dataset