Nephros HydraGuard 10” UltraFilter – Flush

Basic Information

• Brand Name: Nephros HydraGuard 10” UltraFilter – Flush
• Primary DI: 00866318000343
• Version / Model: 70-0112
• Company Name: NEPHROS, INC.
• Labeler DUNS: 120664557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-31
• Public Version: 6
• Public Version Date: 2024-02-14
• Public Version Status: Update
• Public Device Record Key: e744af4c-95e0-4c73-b886-29cd4ef377bd

Device Description

Description: The Nephros HydraGuard 10” UltraFilter – Flush is a hollow fiber ultrafilter that retains bacteria, viruses, and endotoxin from water. Indications for Use: The HydraGuard 10” UltraFilter - Flush is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filter is not intended to provide wa

Device Characteristics

• Single Use: No
• 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: 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
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35433	Particulate water purification filter	A device designed to remove sediment and other suspended particles from flowing water by creating a mechanical barrier to elements larger than a specified size (e.g., 5 to 10 microns/micrometres); it is often made of polypropylene filaments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20866318000347	GS1	Carton Box	30	In Commercial Distribution
Package	10866318000340	GS1	Filter Box	1	In Commercial Distribution
Primary	00866318000343	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161467	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 95 Degrees Fahrenheit