Product code PEH

Device name

Hemodialysis Catheter Luer End Cap

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5540

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For use in hemodialysis catheters to reduce hub infection.

Source

FDA openFDA device classification dataset