K2 Scientific, LLC
25 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal…
25 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDF-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 → 2016.
Who Else Makes It
Concentrated in Shandong (3), Anhui (2), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao Haier Biomedical Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 3 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Aikang Medtech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 5 |
| MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd. | Pidu District Chengdu | Sichuan | Manufacturer | 3 |
| Midea Biomedical Co., Ltd. | Hefei | Anhui | Manufacturer | 2 |
| Zhejiang Heli Refrigeration Equipment Co., Ltd. | Jinhua | Zhejiang | Manufacturer | 1 |
| Zhongke Meiling Cryogenics Company Limited. | Hefei | Anhui | Manufacturer | 1 |
Record
| Listed by | K2 Scientific, LLC |
|---|---|
| FDA product code | KSE |
| Device type | Refrigerator, Freezer, Blood Storage |
| Device class | Class 2 |
| Regulation | 21 CFR 864.9700 |
| Premarket notification | Exempt |
| Record published | 2022-01-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K225SDFBB | In distribution | |
| K225SDRBB | In distribution | |
| K225SDRSSBB | In distribution | |
| K249SDFBB | In distribution | |
| K249GDRSSBB | In distribution | |
| K230SDRSSBB | In distribution | |
| K249GDRSDSSBB | In distribution | |
| K249SDRSSBB | In distribution | |
| K230GDRBB | In distribution | |
| K225GDRBB | In distribution | |
| K230GDRSSBB | In distribution | |
| K230SDRBB | In distribution | |
| K225SDFSSBB | In distribution | |
| K215SDFBBBF | In distribution | |
| K212GDRBB | In distribution | |
| K249GDRBB | In distribution | |
| K249SDRBB | In distribution | |
| K249SDFSSBB | In distribution | |
| K225GDRSSBB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| B Medical Systems | B Medical Systems Sarl | 104 |
| Follett | Follett Corporation | 97 |
| i.Series® | Helmer Inc. | 69 |
| Horizon Series™ | Helmer Inc. | 59 |
| Haier | Qingdao Haier Biomedical Co., Ltd. | 41 |
| Thermo Scientific | KEY Scientific Inc | 29 |
| Thermo Scientific Jewett Blood Bank Refrigerator | KEY Scientific Inc | 27 |
| Thermo Scientific ™ CryoMed™ | Thermo Fisher Scientific (Asheville) LLC | 24 |
| Biotecno | Biotecno Industria E Comercio Ltda | 23 |
| Thermo Scientific TSX Series High-Performance Plasma Freezer | KEY Scientific Inc | 20 |
| Thermo Scientific Forma Blood Bank Refrigerator | KEY Scientific Inc | 19 |
| Thermo Scientific Revco Freezer | KEY Scientific Inc | 19 |
Showing 12 of 73. All products under Refrigerator, Freezer, Blood Storage
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.