SSU-D with Orifice

GUDID 10896241002517

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.

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• Primary Device ID: 10896241002517
• NIH Device Record Key: e2ad5672-aa3f-42b9-a70b-4262a61b2446
• 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	00896241002510 [Primary]
GS1	10896241002517 [Package]; Contains: 00896241002510; Package: Filter Box [1 Units]; In Commercial Distribution
GS1	20896241002514 [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-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