DSU Dome Dialysis

Basic Information

• Brand Name: DSU Dome Dialysis
• Primary DI: 00896241002121
• Version / Model: 70-0235D
• Company Name: NEPHROS, INC.
• Labeler DUNS: 120664557
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 6
• Public Version Date: 2024-02-14
• Public Version Status: Update
• Public Device Record Key: a3833d1f-c870-47d9-a436-d8c274e06986
• Distribution End Date: 2024-02-13

Device Description

The Nephros DSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).

Device Characteristics

• Single Use: No
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58087	Microbial water purification filter, sterilizable	A device designed to remove general bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, rinsing of medical devices (e.g., endoscopic), body washing/showering of patients, and balneotherapy. This is a reusable device that must be sterilized daily.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10896241002128	GS1	Carton Box	12	Not in Commercial Distribution	2024-02-13
Primary	00896241002121	GS1