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CLEARinse CTS is intended to collect and transport clinical nasal wash aspirate specimens that may contain influenza A or influenza B virus, by health care professionals, from the collection site to a laboratory or testing site. CLEARinse CTS specimens are suitable for use with legally marketed lateral flow immunoassays and molecular assays. CLEARinse CTS is for professional in-vitro diagnostic use.

CLEARinse CTS is intended to collect and transport clinical nasal wash aspirate specimens that may contain influenza A or influenza B virus, by health care professionals, from the collection site to a laboratory or testing site. CLEARinse CTS specimens are suitable for use with legally marketed lateral flow immunoassays and molecular assays. CLEARinse CTS is for professional in-vitro diagnostic use. The product is an extension of the CLEARinse Pro device, a 510(k)-cleared (K082762) professional use medical device with indications for nasal lavage as well as mucus sample collection for subsequent testing. The CLEARinse Pro Handle and Instructions for Use are required for use of the CLEARinse CTS. The CLEARinse CTS is comprised of two component assemblies: a revision to the 510(k)cleared Wash Head and a Transport Container to protect the Wash Head and specimen during transit. The CLEARinse CTS. used with the CLEARinse Pro Handle, will allow a nasal wash aspirate specimen to be collected by a medical professional, protected for transit, and ground shipped to a testing site. The user mounts the CLEARinse CTS Wash Head onto the CLEARinse Pro Handle and adds sterile saline as directed. The tip of the Wash Head is inserted into the patient's nostril and sterile saline is introduced. The irrigated saline and nasal secretions are then aspirated back into the Wash Head, collecting the specimen to be tested. The CLEARinse CTS Wash Head is removed from the Handle and placed into the Transport Container assembly (Container Cup, Filter Seal, Silicone Seal, and Container Lid) and then back into the CLEARinse CTS box for ground transportation of the specimen to a laboratory for testing. The Wash Head is manufactured from inert, biocompatible plastics and is supplied as a sterile, single use device. The Transport Container is also manufactured from inert, biocompatible plastics and is a single use device but is not supplied sterile.

The Aardvark Medical Device is intended for use in nasal and sinus lavage. The device facilitates instillation of saline into the nasal passage and provides powered suction to either 1) directly evacuate the nasal passage, or 2) to remove the fluid and effluent by aspirating from the opposite nostril in a maneuver similar to the Proetz displacement or Aspiration Irrigation Maneuver. The device is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh and mucopurulent or crust secretions. Such conditions and disorders include: Rhinitis (as a symptom of colds, allergies, etc.) and both acute and chronic Sinusitis. It can also be used to collect mucus samples for subsequent testing. It is intended for use in adults and children in either the physician's office or in the home.

The Aardvark device is designed to make nasal and sinus lavage easy and convenient. The device facilitates instillation of salinc into the nasal passage. It then provides mild powered suction to remove the fluid from the nostril. Alternatively, it can bc used on the opposite nostril while intermittently occluding the sprayed nostril, i.e., the Proetz Displacement mancuver. The device consists of a hand held battery opcrated unit with a disposable tip portion. A charger is provided with the device.