Keenhealth

Basic Information

• Brand Name: Keenhealth
• Primary DI: 08719699632530
• Version / Model: K-NW-237
• Company Name: Sevenground Trading B.V.
• Labeler DUNS: 492177197
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-17
• Public Version: 1
• Public Version Date: 2019-05-27
• Public Version Status: New
• Public Device Record Key: a9a39fb9-5184-4baf-8df0-3b00d2cda512

Device Description

K-NW-237 is a nasal wash bottle

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
41599	Nasal irrigation applicator	A dispensing device (e.g., a horn-shaped cup or holder, an irrigation bottle, or a device shaped like a tea pot with a bulbous tipped spout) used to apply a liquid treatment, usually a saline solution, directly to the nasal cavity via the nares, typically to clear and clean the mucous membrane and the nasal channels. Typically made of plastic or as a crockery vessel, the device may include a lid and separate base. It may be known as a nose horn because of its design or a Neti pot and is intended for home-use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719699632530	GS1

Customer Contacts

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