Bufferizer
Catalogue number 5093, listed by Helena Laboratories, Corp., United States, under Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use. 72 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (15), Guangdong (13). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Yancheng Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| HUA Cheng XIN Plastic Mold Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangzhou Komaspec Mechanical AND Electrical Products Manufa | Huashan Town, Huadu District | Guangdong | Contract manufacturer | 4 |
| Inplast Plastic & Electronics Co., Ltd. | Suzhou New District | Jiangsu | Contract manufacturer | 2 |
| Flextronics Medical Molding (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
Showing 12 of 72. All 72 manufacturers in China registered for Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Record
| Listed by | Helena Laboratories, Corp., United States |
|---|---|
| FDA product code | LXG |
| Device type | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-03-17 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5093 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Globe Scientific | Globe Scientific, LLC | 144 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Scientific Device Laboratory, Inc. | 61 |
| Gongdong | Zhejiang Gongdong Medical Technology Co., Ltd. | 26 |
| Cardinal Health | Cardinal Health 200, LLC | 24 |
| De-/Recapper 900 Flex ID, 115V | Sarstedt Aktiengesellschaft & Co.KG | 20 |
| CellSHILED | Equashield Medical Ltd | 19 |
| Porex SQ-Easy | Porex Corporation | 17 |
| Corning | Corning Incorporated | 15 |
| Pathfinder | AIM LAB Automation Technologies PTY Ltd | 15 |
| Yingtai | Changsha Yingtai Instrument Co., Ltd. | 13 |
| Helmer Scientific | Helmer Inc. | 12 |
| Kbmed | KB Medical (Group) Inc. | 11 |
Showing 12 of 424. All products under Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-05-02 | Class II | Process design | Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in re | 32 units |
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.