Tetra Micro
Tetra Micro Syringe Adapter 10mL
2manufacturers in China registered for this device type
5catalogue numbers in this listing
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) | K251105 |
| Record published | 2026-02-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: store between uses in a cool, dry place; Handling environment temperature 20 to 25 °C; Handling environment humidity 30 to 60 % RH; Handling environment atmospheric pressure 700 to 1000 millibar |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FP-0010216 | In distribution | |
| FP-0010215 | In distribution | |
| TM-50 | In distribution | |
| TM-20 | In distribution | |
| FP-0010214 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| FreedomEdgeTM | Repro-Med Systems, Inc. | 1 |
| SCIg60 | Emed Technologies Corporation | 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.