EndoPur Endotoxin 10" Filter Fin

GUDID 20866318000361

Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Fin is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. 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 (Reverse Osmosis, Deionization, 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

• Primary Device ID: 20866318000361
• NIH Device Record Key: 23021270-501f-4125-a6a0-b408e783d03a
• Commercial Distribution Discontinuation: 2017-12-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EndoPur Endotoxin 10" Filter Fin
• Version Model Number: 70-0110F
• 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	00866318000367 [Primary]
GS1	10866318000364 [Package]; Contains: 00866318000367; Package: 1 part per box [1 Units]; Discontinued: 2017-12-18; Not in Commercial Distribution
GS1	20866318000361 [Package]; Contains: 10866318000364; Package: 30 boxes per carton [30 Units]; Discontinued: 2017-12-18; Not 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-15
• Device Publish Date: 2017-09-29

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