Blom - Singer ® Voice Prostheses – Auto Control Medical
TECHNOLOGICAL CHARACTERISTICSThe Blom-Singer Indwelling 2000 Voice Prosthesis is provided for the same indications for useas its predicate devices, the Blom-Singer Indwelling Low Pressure Voice Prosthesis and theProvox 2 Voice Prosthesis.
Blom Singer - Voice Prosthesis Cleaning System - …
PREDICATE DEVICESThe Blom-Singer Indwelling 2000 Voice Prosthesis and its accessory devices are substantiallyequivalent in design and indications for use to the following devices currently in commercialdistribution:- InHealthIndwel1ing Voice Prosthesis, Helix Medical, Carpinteria, CA; K932l2O- Provox2 Voice Rehabilitation System, ATOS Medical AB, Horby, Sweden; K97l244The Blom-Singer Indwelling 2000 Voice Prosthesis Accessory Devices are either /Class Idevices not subject to 510(k) or are substantially equivalent to the following devices:- InHealth Blom-Singer Low Pressure Voice Prosthesis Gel Cap Insertion System, HelixMedical, Carpinteria, CA; K930105 (Inserter Tool and Gel Caps)- InHealth Blom-Singer Flushing Pipet, Helix ‘Medical, Carpinteria, CA; K932163 (FlushingDevice)° InHealth Blom-Singer Indwelling Plug Insert Accessory Device, Helix Medical, Carpinteria,CA; K945288 (Plug Insert)IV.
The Blom-Singer Laryngectomy Tube Flexibly Contours to the Postoperative Tracheal Anatomy by a trained clinician for use with a Blom-Singer voice prosthesis.
Blom Singer Classsic Indwelling Voice Prosthesis 10 …
For users of the 16 Fr. prostheses, use an 18 Fr. dilator; for users of the 20 Fr. prostheses, use a 22 Fr. dilator. The Gel Cap Insertion System enables smooth, easy insertion of Blom-Singer Low Pressure Voice Prostheses into the tracheoesophageal passage. A new flushing pipet allows the voice prostheses to remain in the tracheoesophageal passage while performing routine cleaning.
Blom-Singer Voice Prostheses Accessories
The Blom-Singer tracheostoma valve as a valuable addition in Surgical and prosthesis-related complications using the Groningen button voice prosthesis.
for use with a Blom-Singer Voice Prosthesis.
A full line of accessory items for Blom-Singer Voice Prostheses facilitates routine care and daily maintenance. The tracheoesophageal puncture dilator prevents the tracheoesophageal passage from closing upon removal of the voice prostheses.
the Blom-Singer® Classic™ Indwelling Voice Prostheses ..
Available in two styles, Duckbill and Low Pressure, and multiple sizes, Blom-Singer Voice Prostheses are designed to accommodate most anatomies. Custom sizes and side port are available on special order. Insertion sticks and instruction manual included with each prostheses.
Blom Singer Low Pressure Voice Prosthesis ''14 mm L, 16 …
Blom-Singer® voice prostheses are made of a silicone tube and one-way valve which help to maintain an essential passage between the trachea and the esophagus so that voice can be produced.
Blom Singer Low Pressure Voice Prostheses - ExpressMed
INTENDED USEThe Blom-Singer Indwelling 2000 Voice Prosthesis is for voice rehabilitation following totallaryngectomy where placement of the voice prosthesis is done by a clinician.