I.series®
Laboratory/Pharmacy Refrigerator - Undercounter, 5 cu ft
9manufacturers in China registered for this device type
69catalogue numbers in this listing
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 | Helmer Inc., United States |
|---|---|
| FDA product code | KSE |
| Device type | Refrigerator, Freezer, Blood Storage |
| Device class | Class 2 |
| Regulation | 21 CFR 864.9700 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-07-01 |
| Record revised | 2020-06-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2021-05-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| iLR120 | In distribution | |
| iUF124 | In distribution | |
| iLR111 | In distribution | |
| iLR245-GX | In distribution | |
| iPF104-ADA | In distribution | |
| iBF105-GX | In distribution | |
| iLR105 | In distribution | |
| iLF105-GX | In distribution | |
| iLF105 | In distribution | |
| iPR226-GX | In distribution | |
| iBR120-GX | In distribution | |
| iB225 | In distribution | |
| iB125 | In distribution | |
| iUF116 | In distribution | |
| iLR104-ADA | In distribution | |
| iB111 | In distribution | |
| iLR256 | In distribution | |
| iPR111 | In distribution | |
| iLR120-GX | In distribution | |
| iLR245 | In distribution | |
| iLF120-GX | In distribution | |
| iPR120-GX | In distribution | |
| iPF120 | In distribution | |
| iUF126 | In distribution | |
| iLR105-GX | In distribution | |
| iB456 | In distribution | |
| iPF125 | In distribution | |
| iBR125-GX | In distribution | |
| iBR256-GX | In distribution | |
| iPR245 | In distribution | |
| iPR125-GX | In distribution | |
| iLR125-GX | In distribution | |
| iB104-ADA | In distribution | |
| iBR113-GX | In distribution | |
| iLR125 | In distribution | |
| iB105 | In distribution | |
| iLF120 | In distribution | |
| iBR245-GX | In distribution | |
| iPR125 | In distribution | |
| iBR226-GX | In distribution | |
| iB120 | In distribution | |
| iPR120 | In distribution | |
| iLF104-ADA | In distribution | |
| iPF105 | In distribution | |
| iPR256-GX | In distribution | |
| iBR458-GX | In distribution | |
| iPR105-GX | In distribution | |
| iB256 | In distribution | |
| iBF120-GX | In distribution | |
| iBX020 | In distribution | |
| iPR458-GX | In distribution | |
| iPR225 | In distribution | |
| iUF118 | In distribution | |
| iPR456 | In distribution | |
| iBX080 | In distribution | |
| iLR256-GX | In distribution | |
| iLR113-GX | In distribution | |
| iLF125 | In distribution | |
| iPR245-GX | In distribution | |
| iB245 | In distribution | |
| iLF125-GX | In distribution | |
| iPR256 | In distribution | |
| iPR113-GX | In distribution | |
| iBF125-GX | In distribution | |
| iBX020-GX | In distribution | |
| iBR105-GX | In distribution | |
| iBX080-GX | In distribution | |
| iPR458-GX | Withdrawn | |
| iUF124-GX | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| B Medical Systems | B Medical Systems Sarl | 104 |
| Follett | Follett Corporation | 97 |
| 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 |
| K2 Scientific, LLC | K2 Scientific, LLC | 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.