EndoPur Endotoxin 10" Filter Flat

GUDID 20866318000354

Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Flat 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: 20866318000354
• NIH Device Record Key: c15f4593-5073-443b-9511-464780f26091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoPur Endotoxin 10" Filter Flat
• Version Model Number: 70-0110
• 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	00866318000350 [Primary]
GS1	10866318000357 [Package]; Contains: 00866318000350; Package: 1 part per box [1 Units]; In Commercial Distribution
GS1	20866318000354 [Package]; Contains: 10866318000357; Package: 30 boxes per Carton [30 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: 4
• Public Version Date: 2020-01-20
• Device Publish Date: 2017-07-18

On-Brand Devices [EndoPur Endotoxin 10" Filter Flat]

• 20866318000358: Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains
• 20866318000354: Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains