Product code PQH

Device name

Iodinated Contrast Media Transfer Tubing Set

Medical specialty

General Hospital

Device class

2

Regulation number

880.5440

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

The iodinated contrast media transfer set is intended to transfer iodinated contrast media from imaging bulk package contrast media in a controlled ambient environment. The transfer set is intended to be used to directly fill multiple sterile single use syringes from an imaging bulk package contrast media bulk package under controlled ambient filling conditions such as a CT suite.

Source

FDA openFDA device classification dataset