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
| Device Type ID | 2752 |
| Device Name | Iodinated Contrast Media Transfer Tubing Set |
| Physical State | Transfer With Swabbable Valve To Directly Connect To Single Use Sterile Syringes. |
| Technical Method | Transfer Set May Include A Swabbable One Way Valve To Aid In Filling Of Single Use Sterile Syringes And Prevention Of Microbial Ingress. |
| Target Area | Device Does Not Act On Any Part Of The Body. |
| Regulation Description | Intravascular Administration Set. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2752 |
| Device | Iodinated Contrast Media Transfer Tubing Set |
| Product Code | PQH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRACCO INJENEERING S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ULRICH GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |