EndoPur Endotoxin 10" Filter Flat

GUDID 20866318000358

Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use:

NEPHROS, INC.

Microbial water purification filter, non-sterilizable

• Primary Device ID: 20866318000358
• 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	20866318000358 [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: 3
• Public Version Date: 2018-11-15
• 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