EndoPur Endotoxin 20" Filter

GUDID 20866318000378

Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 20” Filter 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.

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• Primary Device ID: 20866318000378
• NIH Device Record Key: 6310d47f-a519-4629-91c5-687a4bdad7f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoPur Endotoxin 20" Filter
• Version Model Number: 70-0120
• 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	00866318000374 [Primary]
GS1	10866318000371 [Package]; Contains: 00866318000374; Package: 1 part per box [1 Units]; In Commercial Distribution
GS1	20866318000378 [Package]; Contains: 00866318000374; Package: 15 boxes per carton [15 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-15
• Device Publish Date: 2017-07-18

On-Brand Devices [EndoPur Endotoxin 20" Filter ]

• 20866318000378: Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bac
• 10896241002685: Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bac