InHealth Technologies; Blom-Singer®

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer®
• Primary DI: 00848253003115
• Version / Model: TP 2208-LEF
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-03
• Public Version: 2
• Public Version Date: 2025-02-10
• Public Version Status: Update
• Public Device Record Key: e56623f1-1c03-4bec-84e0-30c4c9509076

Device Description

Blom-Singer® FirstFit Surgical Kit with 22.5Fr Voice Prosthesis, 8mm length

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: Yes
• 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
36071	Tracheostomy tube speech valve	A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.	No	Active
65394	Tracheoesophageal speech valve guidewire	A hand-held flexible wire intended to assist surgical placement of an indwelling tracheoesophageal speech valve into a tracheoesophageal fistula (puncture). It incorporates a distal connector onto which the speech valve is attached prior to guidewire advancement through a tracheostoma or endoscope; it may in addition be used for the transoral removal of a tracheoesophageal speech valve before introducing its replacement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848253003115	GS1

Customer Contacts

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