SSU Dome Dialysis

GUDID 10896241002227

The Nephros SSU-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.).

NEPHROS, INC.

Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable

• Primary Device ID: 10896241002227
• NIH Device Record Key: 738eec88-78af-413a-a204-bbde603660b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SSU Dome Dialysis
• Version Model Number: 70-0243D
• Company DUNS: 120664557
• Company Name: NEPHROS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896241002220 [Primary]
GS1	10896241002227 [Package]; Contains: 00896241002220; Package: Filter Box [1 Units]; In Commercial Distribution
GS1	20896241002224 [Package]; Package: Carton Box [12 Units]; In Commercial Distribution

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-24
• Device Publish Date: 2021-09-16

On-Brand Devices [SSU Dome Dialysis]

• 10896241002210: SSU Dome Dialysis and packaging information
• 10896241002227: The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemo