PROTEC

Basic Information

• Brand Name: PROTEC
• Primary DI: 00328785835021
• Version / Model: PWF2
• Company Name: KAZ USA, INC.
• Labeler DUNS: 122612547
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2018-08-31
• Public Version: 2
• Public Version Date: 2020-05-27
• Public Version Status: Update
• Public Device Record Key: b3d81533-27bd-46ea-a78c-ca7b1e536903

Device Description

HUMIDIFIER FILTER, WICKING, WF2, PROTEC

Device Characteristics

• Single Use: Yes
• 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: No
• 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
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	868.5460	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16759	Room humidifier	A mains electricity (AC-powered) device intended to add moisture to ambient air, typically to prevent dryness of a patient's airways. This is a stationary device designed to be placed in one location in a room, typically in a hospital, institution, home, or office environment; it can be physically lifted and moved to another position or room. It typically consists of an electric motor, a reservoir for water, an atomizer to produce large mist particles, and a flow diverter. The water reservoir is periodically topped up with clean (preferably purified) water. Moisture is released directly into the room's atmosphere.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10328785835028	GS1	CASE	6	In Commercial Distribution
Primary	00328785835021	GS1
Unit of Use	20328785835025	GS1

Customer Contacts

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