InHealth Technologies; Blom-Singer; Dual Valve

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer; Dual Valve
• Primary DI: 00813307010968
• Version / Model: DV 2012-NS
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-01
• Public Version: 4
• Public Version Date: 2021-01-12
• Public Version Status: Update
• Public Device Record Key: e968bd15-998e-4e97-99a7-c68362161366

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	874.3730	2
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	868.5795	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62095	Airway device cleaning utensil, invasive	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.	No	Active
62096	Tracheoesophageal speech valve irrigation device	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.	No	Active
62127	Tracheoesophageal device introducer	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.	No	Active
62134	Tracheoesophageal device insertion capsule	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.	No	Active
42533	Tracheoesophageal speech valve, indwelling	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813307010968	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight; Keep dry