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