Posted: September 11, 2018 |
AMSure® Sterile Water and Sterile Normal Saline for Wound Flush Receives FDA 510(k) Clearance
Pomona, Ca — Amsino Medical Group announces that the AMSure sterile water and sterile normal saline for wound flush has received United States Food and Drug Administration (FDA) 510(k) clearance as an unclassified pre-amendment device for both over-the-counter and prescription use, marking the expansion of Amsino manufactured saline and sterile water products in the industry.
“As we move forward with the expansion of our saline and sterile water products, we are enthusiastic about the new direction and growth of the of the company. This is another step in supporting healthcare as an FDA cleared source for sterile water and sterile normal saline products” said Chairman and CEO of Amsino, Dr. Richard Y. Lee.
Sterile water and sterile normal (0.9%) saline for wound flush is the newest product included in the AMSure Surgical Nursing Solutions line that provides everyday patient care solutions. The sterile water and sterile normal saline for wound flush is USP purified water and gamma irradiated to support infection control practices and patient safety. Available in 100 mL single use bottles and is indicated for the moistening and debriding of dermal wounds or device irrigation in both clinical and home care settings.
Amsino’s superior quality and technological advancements have gained the trust of healthcare professionals worldwide. The addition of sterile water and sterile normal saline manufacturing has allowed Amsino to broaden the breadth of its business model and expand product offerings to new markets, positioning the company for huge growth and market share globally in the industry.
Established in the U.S. in 1993, Amsino develops, manufactures and markets medical products that help improve the safety and effectiveness of patient care under a portfolio of globally recognized Amsino brands. We operate several U.S. FDA qualified manufacturing and R&D facilities globally under ISO13485 quality management system.