Device class
Class II
Regulation 880.5725
Total clearances
4
2022-10-13 → 2025-12-22
Definition
What is Immunoglobulin G (Igg) Infusion System
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.
Classification details
Medical specialty
General Hospital
Regulation number
880.5725
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 96365 |
CPT
|
— |
High
|
Intravenous infusion for subcutaneous IgG delivery setup and administration |
| 96367 |
CPT
|
— |
Medium
|
Subcutaneous infusion of biological agent (IgG) with extended infusion time |
Pulse
Most recent 510(k) clearances