SCIg60 Infusion System
The SCIg60 Infuser is the reusable mechanical pump in the SCIg60 infusion system. It is used for subcutaneous delivery of Hizentra 20% human immune globulin in home or hospital settings and…
The SCIg60 Infuser is the reusable mechanical pump in the SCIg60 infusion system. It is used for subcutaneous delivery of Hizentra 20% human immune globulin in home or hospital settings and requires the BD 60mL syringe, model 309653.
A spring applies pressure to the filled syringe, moving liquid through the connected tubing. The pump operates without batteries or an electrical supply. It works with the system’s Infuset flow-control extension set and SUB-Q patient administration set.
Listed Item
SCIg60 Infuser (Mechanical Pump) Assembly
Flow Control
The extension tubing’s length and inner diameter determine the flow rate under the pump’s pressure. Different specified tubing and needle-set combinations provide different infusion rates, while slide clamps on the extension set can stop flow.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Emed Technologies Corporation, United States |
|---|---|
| FDA product code | PKP |
| Device type | Immunoglobulin G (Igg) Infusion System |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K142319 |
| Record published | 2016-09-23 |
| Record revised | 2025-01-14 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -5 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FP-0010002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tetra Micro | Emed Technologies Corporation | 5 |
| FreedomEdgeTM | Repro-Med Systems, Inc. | 1 |
| SCIg60 | Emed Technologies Corporation | 1 |
| FREEDOM60® | Repro-Med Systems, Inc. | 1 |
| VersaPump Infuser | Emed Technologies Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251105 | 2025-12-22 |
| K240148 | 2024-02-16 |
| K230883 | 2023-11-28 |
| K222087 | 2022-10-13 |
| K173783 | 2018-12-14 |
| K161906 | 2016-12-01 |
| K142319 | 2015-05-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.