Data / Medical devices / Supplies, Blood-Bank
Supplies, Blood-Bank (KSS): 32 FDA-registered makers in 11 countries
32 establishments in 11 countries are registered with the FDA to make Supplies, Blood-Bank (product code KSS, Class 1, 21 CFR 864.9050). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on January 5, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSS
- Device class
- 1
- Regulation
- 864.9050
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 18 |
| China | 3 |
| United Kingdom | 2 |
| Japan | 2 |
| Poland | 1 |
| Italy | 1 |
| Dominican Republic | 1 |
| Germany | 1 |
| Malaysia | 1 |
| Canada | 1 |
| Israel | 1 |
Makers of Supplies, Blood-Bank
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 |
|---|---|---|---|---|---|---|---|---|
| Advanced Engineering, Inc. | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alba Bioscience Limited | PENICUIK Midlothian, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpha Scientific Corp. | Exton, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ashland Specialty Ingredients, G.P. | Bridgewater, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Cleveland, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinico Medical Sp. z o.o. | Blonie/Miekinia Dolnoslaskie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Delcon SRL | Grassobbio Bergamo, Italy | 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 | |
| Fresenius Hemocare GMBH | Friedberg Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GVS TM, Inc. | Covina, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immucor, Inc. | Norcross, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itl Asia Pacific Sdn Bhd | Batu Gajah Perak, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Goju Identification Technology Co., Ltd. | YANCHENG CITY Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LCR Hallcrest, LLC. (IL) | Glenview, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Typing Systems, Inc. | Pompano Beach, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nichiryo Co., Ltd | Saitama-City, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radtag Technologies, Inc. | EDMONTON Alberta, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Lilian Precision Mould Manufacturing Co., Ltd. | Shenzhen City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tessy Plastics Corp. | Elbridge, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Timestrip Uk Limited | SUDBURY Suffolk, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo BCT, Inc.. | Lakewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Corporation Fujinomiya Factory | FUJINOMIYA-SHI Shizuoka, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Timestrip Technical Services Ltd. | Even Yehuda Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Typenex Medical, LLC | Chicago, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Web Industries | Dayville, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zebra Technologies Corporation | Morris Plains, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 5, 1988. 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.