IN-DATE
IN2008-SO-SD: InHealth Blom-Singer Classic Indwelling Voice Prosthesis 20F / 8mm
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| Price: | $149.99 per kit |
|---|---|
| Quantity: | |
| In Stock: | 1 kits |
| Expiration: | 10-2026 |
| Express: | Need it tomorrow? Order in next 13 hours 33 minutes and choose overnight shipping at checkout for Monday delivery. If you require Saturday delivery, please call to determine if it is available in your area - 888-416-2409. |
Additional Details
Freudenberg Medical InHealth Blom-Singer Classic Indwelling Voice Prosthesis
- Voice Prosthesis
- Secondary Placement Kit
- Cleaning System
AccessGUDID Info
- FDA Product Code: EPE
- FDA Product Code Name: Brush, Cleaning, Tracheal Tube
- FDA Product Code: EWL
- FDA Product Code Name: Prosthesis, Laryngeal (Taub)
- GMDN Term Code: 62127
- GMDN Term Name: Tracheoesophageal device introducer
- GMDN Term Description: A hand-held manual instrument designed to assist in the non-surgical placement of a tracheoesophageal device (e.g., speech valve, speech valve occluder, fistula gauge/dilator). It is a synthetic polymer holder onto which the tracheoesophageal device is distally mounted and directed to the target site through the tracheostoma. It is intended to be used by the patient at home (for non-indwelling devices) and clinician in the healthcare facility (for indwelling devices). This is a single-use device.
- GMDN Term Code: 62134
- GMDN Term Name: Tracheoesophageal device insertion capsule
- GMDN Term Description: A non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. This is a single-use device.
- GMDN Term Code: 62096
- GMDN Term Name: Tracheoesophageal speech valve irrigation device
- GMDN Term Description: A non-sterile hand-held device intended to be used for the in situ washing of an indwelling tracheoesophageal speech valve by water irrigation to remove organic matter (e.g., phlegm). It is in the form of a water-fillable squeeze bulb with a distal nozzle that is inserted through the tracheostoma into the central lumen of the valve; it is intended to be used routinely by a patient in the home. This is a reusable device.
- GMDN Term Code: 62095
- GMDN Term Name: Airway device cleaning utensil, invasive
- GMDN Term Description: A non-sterile hand-held device intended to be used to clean an in situ airway device (e.g., indwelling tracheoesophageal speech valve, laryngeal airway). It is inserted into the central lumen of the device and typically rotated multiple times to remove organic matter (e.g., phlegm); it may also be used to clean an airway device ex situ (i.e., once it has been removed from the patient). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.
- GMDN Term Code: 42533
- GMDN Term Name: Tracheoesophageal speech valve, indwelling
- GMDN Term Description: A device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced on an as needed basis by a speech pathologist or clinician. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The patient periodically cleans the device in situ. Disposable devices associated with implantation/insertion may be included. This is a single-use device.
Manufacturer
InHealth Technologies is a Freudenberg Medical company focused on laryngectomy and ENT care solutions, with a long-standing presence in voice restoration, pulmonary rehabilitation, and related airway management products. Known for the Blom-Singer line, InHealth serves clinicians and patients with devices and accessories designed to support speech, breathing, and quality of life after laryngectomy. The company operates as a division and brand of Freudenberg Medical, LLC, combining specialized clinical expertise in voice restoration with the broader manufacturing and engineering capabilities of the Freudenberg Medical organization.
