InHealth Technologies; Blom-Singer

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer
• Primary DI: 00813307013112
• Version / Model: BE 6096
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-01-01
• Public Version: 3
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 01a87927-3c27-475a-9b40-89cfbb2c53cf

Device Characteristics

• Single Use: Yes
• 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: No

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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813307013112	GS1
Unit of Use	00848253002644	GS1

Customer Contacts

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