Data / Medical devices / Infusor, Pressure, For I.V. Bags
Infusor, Pressure, For I.V. Bags (KZD): 56 FDA-registered makers in 9 countries
56 establishments in 9 countries are registered with the FDA to make Infusor, Pressure, For I.V. Bags (product code KZD, Class 1, 21 CFR 880.5420). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on February 17, 1998, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KZD
- Device class
- 1
- Regulation
- 880.5420
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 19 |
| United States | 18 |
| Mexico | 6 |
| Taiwan | 4 |
| Germany | 3 |
| Indonesia | 2 |
| United Kingdom | 2 |
| Austria | 1 |
| South Korea | 1 |
Makers of Infusor, Pressure, For I.V. Bags
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 |
|---|---|---|---|---|---|---|---|---|
| Medical Solutions, Inc. | Chantilly, VA, United States | Specification developer | 1 | October 29, 1997 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amis (xiamen) Cultural Creativity Co., Ltd | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biegler GMBH | MAUERBACH Niederosterreich, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | Ciudad Juarez Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | Lafayette, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foremount Enterprise Co., Ltd. | Taichung City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Amk Medical Equipment Co.,ltd. | Guang zhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc | Salt Lake City, UT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iimed Medical Mexicana S. De R.L. De C.V. | Reynosa Tamaulipas, Mexico | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mason Tayler Medical Products Corp. | Buffalo, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcreat ( Guangzhou ) Bio-Tech Co.,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med-Linket Corp | Alhambra, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDIKAN CO., Ltd. | Gangseo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Albert Novosino Co., Ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Kk-Bioscience Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Newlife Healthcare International | Kota Administrasi Jakarta Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Purple Surgical International Limited | Herts England, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Purple Surgical Manufacturing Limited | Taunton Somerset, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Renu Medical, Inc. | Everett, WA, United States | Complaint file establishment, Repackager or relabeler, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Riester GMBH | JUNGINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Gaohui Rubber And Plastic Products Co., Ltd | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Med-Link Electronics Tech Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sugih Instrumendo Abadi, PT | Bandung Barat Jawa Barat, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunmed Ap, Ltd. | ZHUHAI Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salter Labs | El Paso, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Caremate Medical Device Co. Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Eden Prairie, MN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Minhua Medical Equipment Co.,Ltd. | SuZhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Metrix Company | Dubuque, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiger Medical Group | Shanghai, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Transparent Supply Solutions Ltd. | Dover, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tapmedic | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiantai Shengtengyun Medical Supplies Co., Ltd. | TIANTAI COUNTY Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimax Medical Systems Inc. | New Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimax Medical Systems Inc. | Yilan County, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimed Medical Supplies Inc | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VBM Medizintechnik GMBH | SULZ AM NECKAR Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vincent Medical (dong Guan) Manufacturing Co., Ltd. | Dong Guan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vistar Medical Supplies Co., Ltd. | SHENZHEN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Longwan Medical Device Factory | Wenzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 17, 1998. 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.