InHealth Technologies; Blom-Singer

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer
• Primary DI: 00813307011514
• Version / Model: IN 4050
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2020-09-25
• Public Version Status: Update
• Public Device Record Key: 61c17ba8-90ce-4870-b8e0-6044ac06c3c9

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813307011514	GS1
Unit of Use	00848253002651	GS1

Customer Contacts

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