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.

Microbial water purification filter, non-sterilizable

• 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 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: 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