PQH · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5440
Classification
FDA Product Code
PQH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5440
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.