MXP Processing Bagset
Cell separation processing and collection bag set.
37manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (9), Zhejiang (7), Guangdong (6). 6 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 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Shanghai Gene Era Bio-Science Co., Ltd. | Fengxian | Shanghai | Contract manufacturer | 8 |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan | Guangdong | Contract manufacturer | 5 |
| Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Showing 12 of 37. All 37 manufacturers in China registered for Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Record
| Listed by | ThermoGenesis Corp., United States |
|---|---|
| FDA product code | JQC |
| Device type | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2021-01-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: 15 deg C to 30 deg C, Keep dry |
| Packaging | Case of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8-5137 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thermo Scientific | Thermo Electron LED GmbH | 131 |
| Yingtai | Changsha Yingtai Instrument Co., Ltd. | 39 |
| Globe Scientific | Globe Scientific, LLC | 33 |
| Swing-out rotor | Andreas Hettich Gmbh | 28 |
| LW Scientific, Inc` | LW Scientific, Inc. | 23 |
| Angle rotor | Andreas Hettich Gmbh | 21 |
| Bucket | Andreas Hettich Gmbh | 21 |
| Harvest® SmartPrep® | Terumo BCT, Inc.. | 12 |
| LW Scientific | LW Scientific, Inc. | 12 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 9 |
| ART BMC System Centrifuge | Celling Biosciences | 9 |
| Harvest® | Terumo BCT, Inc.. | 8 |
Showing 12 of 635. All products under Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081345 | 2008-07-10 |
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.