BREATHE COMFORT

Basic Information

• Brand Name: BREATHE COMFORT
• Primary DI: 00850024759138
• Version / Model: NASAL IRRIGATOR
• Company Name: Slv Pharmaceuticals LLC
• Labeler DUNS: 081225162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-18
• Public Version: 1
• Public Version Date: 2020-11-26
• Public Version Status: New
• Public Device Record Key: 38de3e8b-4dd7-4e0d-aa3f-c33fceb9680c

Device Description

Breathe Comfort Nasal Irrigator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	874.5550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44845	Nasal irrigation set, home-use	A collection of non-sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness); it may also be used to create a solution. It typically includes an irrigation bottle/canister, actuator tips and adaptors for various solution-delivery applications, and sometimes packets of sodium-based solutes or prepared solution. It is intended for use in the home. After application, the solution cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850024759138	GS1