SSU Dome Dialysis

GUDID 10896241002210

SSU Dome Dialysis and packaging information

NEPHROS, INC.

Microbial water purification filter, non-sterilizable

• Primary Device ID: 10896241002210
• NIH Device Record Key: 49a758b6-f409-4b85-b837-3be8ab719f78
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896241002213 [Primary]
GS1	10896241002210 [Package]; Contains: 00896241002213; Package: Filter Box [1 Units]; In Commercial Distribution
GS1	20896241002217 [Package]; Package: Carton Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110285

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-21
• Device Publish Date: 2016-09-24

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