VersaPump Infuser
The VersaPump Infuser supplies spring pressure for subcutaneous infusion of specified human immunoglobulin medicines. It is a reusable pump for one patient, used at home or in hospital with…
The VersaPump Infuser supplies spring pressure for subcutaneous infusion of specified human immunoglobulin medicines. It is a reusable pump for one patient, used at home or in hospital with compatible syringes, flow controllers and administration sets. An adult must operate it, including when the patient is a child aged two years or older.
The spring drives the syringe without batteries or an electrical supply. An Infuset fixed flow controller or VersaRate Plus adjustable controller regulates the fluid delivered through a connected SUB-Q administration set. Flow depends on the chosen controller, syringe and needle configuration. The pump has no alarms or display.
Listed Item
The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).
System Compatibility
Use is limited to the labeled immunoglobulin products and specified components. Supported syringe options include selected 20 and 30 mL BD syringes, a 20 mL Hizentra prefilled syringe, a 30 mL B. Braun syringe and a 35 mL Monoject syringe. A carrying case supports mobility during infusion.
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) | K230883 |
| Record published | 2023-12-18 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment temperature -5 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FP-0010209 | 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 |
| SCIg60 Infusion System | 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.