Data / Medical devices / Container, Empty, For Collection & Processing Of Blood & Blood Components
Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR): 19 FDA-registered makers in 8 countries
19 establishments in 8 countries are registered with the FDA to make Container, Empty, For Collection & Processing Of Blood & Blood Components (product code KSR, Class 2, 21 CFR 864.9100). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on December 8, 2003, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSR
- Device class
- 2
- Regulation
- 864.9100
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Dominican Republic | 2 |
| Mexico | 2 |
| Taiwan | 2 |
| United Kingdom | 1 |
| Switzerland | 1 |
| Vietnam | 1 |
| Japan | 1 |
Makers of Container, Empty, For Collection & Processing Of Blood & Blood Components
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | June 13, 2002 | 0 | 1 | 0 | api.fda.gov |
| Charter Medical, LLC | Winston Salem, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal International, Inc. | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GVS TM, Inc. | Covina, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Life Sciences Solutions USA LLC | Marlborough, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemotronic De Mexico S De RL | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemonetics Corporation | Clinton, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemonetics Mexico Manufacturing S. de R.L. de C.V. | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Medical Manufacturing Co. | Zhunan Township, Miaoli County, Taiwan | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OriGen Biomedical, Inc. | Austin, TX, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pall Newquay | Newquay Cornwall, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puriblood Medical Co., Ltd. | Hsinchu Hsinchu(County), Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pall International, Sarl | Fribourg, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo BCT Vietnam Co., Ltd. | Binh An commune Dong Nai, Vietnam | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo BCT, Inc.. | Lakewood, CO, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Corporation Fujinomiya Factory | FUJINOMIYA-SHI Shizuoka, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 8, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.