Definition: An Immunoglobulin G (IgG) Infusion System Is A Prescription Device Intended For Subcutaneous Delivery Of Immunoglobulin G (IgG) In Accordance With The FDA Approved Labeling.
| Device Type ID | 2746 |
| Device Name | Immunoglobulin G (igg) Infusion System |
| Physical State | An Immunoglobulin G (IgG) Infusion System Includes The Delivery Device, Reservoir Or Syringe, And Any Administration Sets And / Or Subcutaneous Catheters Or Needles To Infuse Immunoglobulin G (IgG) Into Subcutaneous Tissue. |
| Technical Method | An Immunoglobulin G (IgG) Infusion System Infuses Immunoglobulin G (IgG) Into Subcutaneous Tissue In Accordance With FDA Approved Labeling. |
| Target Area | In Accordance With FDA Approved Labeling, An Immunoglobulin G (IgG) Infusion System Is For Subcutaneous Infusion Only. |
| Regulation Description | Infusion Pump. |
| 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 | 880.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PKP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2746 |
| Device | Immunoglobulin G (igg) Infusion System |
| Product Code | PKP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EMED TECHNOLOGIES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |