InHealth Technologies; Blom-Singer

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer
• Primary DI: 00813307014423
• Version / Model: IN 1606-LETO
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-01
• Public Version: 4
• Public Version Date: 2020-09-14
• Public Version Status: Update
• Public Device Record Key: 77ab44fa-7df9-4ae4-8576-a1d8823cf629

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
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	874.3730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62134	Tracheoesophageal device insertion capsule	A non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. This is a single-use device.	No	Active
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
62148	Tracheoesophageal fistula spacer/occluder	A non-sterile device intended to be placed in a surgically-created tracheoesophageal fistula/puncture (usually for more than 30 days) to: 1) maintain its shape and patency following total laryngectomy; and 2) to prevent leakage of fluids from the oesophagus into the trachea. It is made of synthetic polymer and includes a double retention flange and a neck fastening strap; it is not intended to enable voice production. It is inserted through the tracheostoma and replaced by a clinician as needed (indwelling type); devices to assist placement may be included. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813307014423	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry; Keep Away From Sunlight