InHealth Technologies; Blom-Singer

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer
• Primary DI: 00813307014720
• Version / Model: IN 4064
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2017-01-01
• Public Version: 4
• Public Version Date: 2020-09-25
• Public Version Status: Update
• Public Device Record Key: b288374c-1277-4549-970e-b946397aba3a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813307014720	GS1
Unit of Use	00848253002668	GS1

Customer Contacts

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