SCIg60
SCIg60 Infusion Pump Carrying Case
2manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
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 | 2020-08-07 |
| Record revised | 2025-01-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FP-0010032 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tetra Micro | Emed Technologies Corporation | 5 |
| FreedomEdgeTM | Repro-Med Systems, Inc. | 1 |
| FREEDOM60® | Repro-Med Systems, Inc. | 1 |
| VersaPump Infuser | Emed Technologies Corporation | 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.