HYDROCLEANSE™

Basic Information

• Brand Name: HYDROCLEANSE™
• Primary DI: 00643169864429
• Version / Model: 1960100
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-09
• Public Version: 1
• Public Version Date: 2018-09-10
• Public Version Status: New
• Public Device Record Key: 689f482c-94bb-42c3-a5ca-57f8bc2e5c8a

Device Description

DEVICE 1960100 SINUS WASH SYSTEM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAR	IRRIGATOR, SINUS	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62449	Nasal irrigation set, clinical	A collection of 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) and/or before, during and/or after ENT surgery. It typically includes an irrigation bottle/canister/syringe which can include a pumping mechanism, actuator tips and adaptors for various solution-delivery applications and connector tubing. This device is intended to be used by a professional in a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169864429	GS1

Customer Contacts

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