FREEDOM60®
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 |
| 510(k) | K162613 |
| Record published | 2016-08-19 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| F10050 | 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 |
| VersaPump Infuser | Emed Technologies Corporation | 1 |
| SCIg60 Infusion System | Emed Technologies Corporation | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Repro-Med Systems, Inc. | 510(k) number | 2016-03-10 | Class II | Nonconforming Material/Component | On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part numb | 2018-02-26 |
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.