Australia - English - Department of Health (Therapeutic Goods Administration)

compliance management solutions - 66625 - physiologic monitor-installed software - biofourmis biovitals analytics engine is intended to be used with continuous biometric data from already cleared sensors measuring heart rate,respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. it learns the correlation between multiple vital signs during the patient?s daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. it computes a time series biovitals index (bi), which reflects changes in the patient?s measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient. it is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. it is intended for review by a qualified practitioner. it is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. it is intended for an adult population.

Australia - English - Department of Health (Therapeutic Goods Administration)

multimedia speech pathology - 43472 - analyser software, application program - computer assisted display and analysis of biometric parameters of the human voice and voice and speech biofeedback therapy aid.

Australia - English - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 32547 - telemetry system, physiological signal - the bodyguardian remote monitoring system detects and monitors biometric parameters in ambulatory patients, when prescribed by a physician or other qualified health care professional. the system continuously records, stores and periodically transmits the data for review, storage, or further processing.

Australia - English - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 31109 - measuring instrument, conductivity, skin - the disposable sensor is connected to a finger probe in order to acquire and transmit signals for the purposes of monitoring skin conductivity levels.

Australia - English - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 33586 - single-patient physiologic monitoring system - the system is intended to be used for assessing changes in pain levels by monitoring the physiological responses to pain, using a relative pain index (nol index) from 0-100, whereas 0 represents no nociception/pain and 100 represents high nociception/pain level. the system consists of a non-invasive finger probe and bedside monitor.

Australia - English - Department of Health (Therapeutic Goods Administration)

cylite pty ltd - 58850 - spectral-domain optical coherence tomography system - the hp-oct? instrument is intended for non-contact measurement and visualization of ocular structures and their optical properties, including the cornea, anterior chamber, iris/pupil, crystalline lens and retina. the measurements of biometric parameters such as corneal curvature and refractive power, cornea thickness, chamber depth, lens thickness, axial length and white-to-white (wtw) distance can be used to assist in the determination of the appropriate power and type of intraocular lens.; the hp-oct? instrument is intended to be used by ophthalmologists, optometrists, and other qualified clinicians only.

Australia - English - Department of Health (Therapeutic Goods Administration)

cylite pty ltd - 58850 - spectral-domain optical coherence tomography system - the hp-oct? instrument is intended for non-contact measurement and visualization of ocular structures including the cornea, anterior chamber, iris/pupil, crystalline lens and retina. the measurements of biometric parameters such as corneal curvature, cornea thickness, chamber depth, lens thickness, axial length and white-to-white (wtw) distance are used to assist in the determination of the appropriate power and type of intraocular lens.

United States - English - NLM (National Library of Medicine)

inopak, ltd - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antiseptic - handwash to help reduce bacteria on the skin that potentially can cause disease. - recommended for repeated use. irritation and redness develop or if condition persists for more than 72 hours.

Canada - English - Health Canada

ferring inc - carbetocin - solution - 100mcg - carbetocin 100mcg - oxytocics

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

andermatt group ag - nuclear polyhedrosis virus of helicoverpa armigera - suspension concentrate - nuclear polyhedrosis virus of helicoverpa armigera biological-virus active 0.0 p - insecticide