InHealth Technologies; Blom-Singer

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer
• Primary DI: 00813307011569
• Version / Model: BE 2050
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-01
• Public Version: 3
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 9b587ecd-985c-4e4d-9631-49bac4a8fa37

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCG	Dilator, Tracheal	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62125	Tracheoesophageal fistula dilator	A hand-held, manual non-surgical instrument intended to dilate a surgically-created tracheoesophageal fistula (puncture) to facilitate insertion of a tracheoesophageal device (typically a non-indwelling tracheoesophageal speech valve); it may in addition be used as a temporary occluder to prevent leakage of fluids from the oesophagus into the trachea. It is a flexible, tapered, synthetic polymer shaft with a handle designed to access the fistula via the tracheostoma. It is intended for transient-use by the patient or clinician, in the home and healthcare facility. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813307011569	GS1

Customer Contacts

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