Address:KRAFTGATAN 8,HORBY Skane,SE
Device Description : Provox HME Cassette Adaptor is intended to facilitate a connection between Provo Provox HME Cassette Adaptor is intended to facilitate a connection between Provox HME Cassette and on the market available tracheal cannulas with ISO-cone (15 mm).For laryngectomies who need a cannula initially or for a longer period of time. Enables immediate start of pulmonary rehabilitation with HME.
Device Class : 1
Duns Number: 355470923
Premarket Exempt : Yes
Prescription Use : No
Device Description : Provox Micron HME is a disposable device that features a calcium chloride-treate Provox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage.
Device Class :
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : Provox Micron HME is a disposable device that features a calcium chloride-treate Provox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage.
Device Class :
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox Adhesives are single use devices intended for laryngectomized patient The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
Device Class : 1
Duns Number: 355470923
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Provox Adhesives are single use devices intended for laryngectomized patient The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
Device Class : 1
Duns Number: 355470923
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Provox Adhesives are single use devices intended for laryngectomized patient The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
Device Class : 1
Duns Number: 355470923
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Provox Adhesives are single use devices intended for laryngectomized patient The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
Device Class : 1
Duns Number: 355470923
Premarket Exempt : Yes
Prescription Use : No
Device Description : Provox ShowerAid is used to temporarily replace the HME during showering. The Sh Provox ShowerAid is used to temporarily replace the HME during showering. The ShowerAid can be placed in all Provox appliance holders.
Device Class : 1
Duns Number: 355470923
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Provox BasePlate Adaptor is an accessory product for rehabilitation after to The Provox BasePlate Adaptor is an accessory product for rehabilitation after total laryngectomy. It allows attaching medical devices with ISO 15mm standard connector to a tracheostoma by fitting it into a Provox Adhesive base plate, Provox LaryButton or Provox LaryTube. A typical example would be to attach an HME with built-in oxygen adapter (TrachPhone). For single patient use.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : No
Device Description : The Provox Adhesives are single use devices intended for laryngectomized patient The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.The FlexiDerm adhesives are Provox FlexiDerm Round/Oval/Plus and Provox XtraBase with a concave shaped base.
Device Class : 1
Duns Number: 355470923
Premarket Exempt : Yes
Prescription Use : No