Harvest® SmartPrep®
SmartPrep® 3 Multi-Cellular Processing System, Balance Weight PRP 20 BMAC® BW-20
37manufacturers in China registered for this device type
12catalogue numbers in this listing
2recalls on this code
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 | Terumo BCT, Inc.., 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, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-15 |
| Record revised | 2023-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Storage environment temperature -40 to 66 °C |
| Distribution end date | 2023-02-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 51475 | Withdrawn | |
| 51495 | Withdrawn | |
| 51494 | Withdrawn | |
| 51470 | Withdrawn | |
| 51482 | Withdrawn | |
| 51488 | Withdrawn | |
| 51491 | Withdrawn | |
| 51490 | Withdrawn | |
| 51498 | Withdrawn | |
| 51486 | Withdrawn | |
| 51478 | Withdrawn | |
| 51487 | Withdrawn |
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 |
| 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 |
| Celling ART BMC System | Celling Biosciences | 8 |
Showing 12 of 635. All products under Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Recalls
2 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2017-10-20 | Class II | Process control | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The expi | 30 units | 2020-08-21 |
| 2017-10-20 | Class II | Process control | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The expi | 281 units | 2020-08-21 |
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.