SSU-D with Orifice

GUDID 10896241002500

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

• Primary Device ID: 10896241002500
• NIH Device Record Key: bd7856b3-b18f-480c-851d-071fb6c26b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SSU-D with Orifice
• Version Model Number: 70-0243O
• 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: false
• 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	00896241002503 [Primary]
GS1	10896241002500 [Package]; Contains: 00896241002503; Package: Carton [10 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: 2021-09-14
• Device Publish Date: 2016-09-24

On-Brand Devices [SSU-D with Orifice]

• 10896241002500: The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemo
• 10896241002517: The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemo