Breather Fit

Basic Information

• Brand Name: Breather Fit
• Primary DI: 00865202000148
• Version / Model: B-Fit
• Company Name: Pn Medical Inc
• Labeler DUNS: 020298966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-09
• Public Version: 1
• Public Version Date: 2024-09-17
• Public Version Status: New
• Public Device Record Key: 604e7e3e-268a-47ab-92b7-f3eed5a14f27

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63278	Tongue/lip exerciser	A hand-held mechanical device intended to provide resistance to tongue and/or lip movements for rehabilitation of oral motor function, typically to aid in swallow and speech therapy, following impairment (e.g., dysphagia, dysarthria) from stroke or other neurological conditions. It consists of an intraoral bulb with a connected handle, similar to an infant pacifier in appearance, made of flexible silicone. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865202000148	GS1