DentaPure 365 Day Independednt Water Bottle Cartridge

Basic Information

• Brand Name: DentaPure 365 Day Independednt Water Bottle Cartridge
• Primary DI: 50732224005503
• Version / Model: DP365B
• Catalog Number: DP365B10
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Labeler DUNS: 057728685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-11-21
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: a57c6351-3561-4045-8f5b-3c2fee548402

Device Description

Independent Water Bottle Cartridge

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIA	Unit, operative dental	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61137	Legionella water purification filter	A device intended to remove Legionella bacteria from flowing water to reduce the risk of Legionella contamination during body washing for hygiene; it is not intended for medical washing/irrigation and is not intended for general microbial filtration. It typically consists of a plastic housing with a connector attached to the water source [e.g., a tap (faucet)] and a filtering membrane [e.g., made of polyethersulfone (PES)]; it may include a distal shower rose/directing nozzle. This is a disposable device not intended to be reprocessed, which has a multiple-patient use application (reusable).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10732224005505	GS1
Primary	50732224005503	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992893	000