Founded around the work of neonatal intensive-care nurse and co-founder Colleen John, R.N., RashEndZ, Inc. makes FDA-registered occlusive wound dressings that deliver continuous topical oxygen through standard medical oxygen supplies. Based in St. Petersburg with an executive office in New York City, the company’s patented GasPort™ platform is designed for hard-to-heal wounds as well as pediatric and perineal skin conditions, without proprietary equipment. Its clinical program includes an FDA-approved Florida hospital safety study and reported case results in pressure injuries and long-term-care wounds.
FDA-Registered Device under 21 CFR 878.4020
registration
FDA Class I General Controls; 21 CFR 878.4020
compliance_program
CE Mark under EU MDR 2017/745 Rule 1
certification
ISO 10993 Testing
compliance_program