InHealth Technologies; Blom-Singer

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer
• Primary DI: 00848253002620
• Version / Model: BE 6040
• 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: 5
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 1d0ab3f7-553d-4507-bc23-7fc4a11e0a84

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
ENW	Catheter, Nasopharyngeal	Ear, Nose, Throat	874.4175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62146	Tracheoesophageal speech test catheter	A non-sterile flexible tube intended to conduct exhaled air from the tracheostoma of a laryngectomized patient, via the nasal cavity, to the oesophagus as part of an oesophageal insufflation test to assess the patient’s ability to produce tracheoesophageal voice and the potential benefit of speech valve placement (via creation of a tracheoesophageal fistula). Disposable devices intended to assist catheter introduction/function (e.g., tracheostoma connector, adhesive tape) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848253002620	GS1
Package	00813307013051	GS1		6	In Commercial Distribution

Customer Contacts

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