FDA device listing
SCIg60 Infusion System
FDA device listing 1661831482 · DimcoGray Corp. DBA DG Medical
Key facts
| Proprietary names | SCIg60 Infusion System |
|---|---|
| Owner/operator | DimcoGray Corp. DBA DG Medical |
| Owner/operator number | 10038945 |
| Product codes | PKP |
| Device names | PKP - Immunoglobulin G (Igg) Infusion System |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5725 |
| Review panels | General Hospital |
| Registered establishments | DIMCOGRAY CORP. DBA DG MEDICAL |
| Establishment registrations | 3007428065 |
| FEI numbers | 3007428065 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database