492 Kit
This kit contains: 2 OF6002 Foam Cabinet Filters, 1 BF5000 Extended Life Bacteria Filter, 1 B316 Final Bacteria Filter.
17manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (7), Guangdong (6), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Shandong Jinlai Huanhai Medical Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 19 |
| Medease Life Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 15 |
| Shenzhen Yimi Care Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 15 |
| Shenzhen Homed Medical Device Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 13 |
Showing 12 of 17. All 17 manufacturers in China registered for Unit, Filter, Membrane
Record
| Listed by | Sunset Healthcare Solutions, Inc., United States |
|---|---|
| FDA product code | JRL |
| Device type | Unit, Filter, Membrane |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-31 |
| Record revised | 2026-01-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OF6002SP | In distribution |
Same Product Code
Showing 12 of 174. All products under Unit, Filter, Membrane
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.