FreedomEdgeTM
Mechanical Syringe Infusion Pump
2manufacturers in China registered for this device type
1catalogue number
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 | Repro-Med Systems, Inc., United States |
|---|---|
| FDA product code | PKP |
| Device type | Immunoglobulin G (Igg) Infusion System |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Record published | 2016-08-19 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Special storage condition: Store in a cool, dry place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F10020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tetra Micro | Emed Technologies Corporation | 5 |
| SCIg60 | Emed Technologies Corporation | 1 |
| FREEDOM60® | Repro-Med Systems, Inc. | 1 |
| VersaPump Infuser | Emed Technologies Corporation | 1 |
| SCIg60 Infusion System | Emed Technologies Corporation | 1 |
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.