HydraGuard 10" UltraFilter - Flush

GUDID 20866318000347

Description: The HydraGuard 10” UltraFilter - Flush is a hollow fiber ultrafilter that retains bacteria, viruses, and endotoxin from water. Indications for Use: The HydraGuard 10” UltraFilter - Flush is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filter is not intended to provide wa

NEPHROS, INC.

Particulate water purification filter

• Primary Device ID: 20866318000347
• NIH Device Record Key: e744af4c-95e0-4c73-b886-29cd4ef377bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydraGuard 10" UltraFilter - Flush
• Version Model Number: 70-0112
• 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: false
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com
• Phone: 201-345-0829
• Email: vashone.thomas@nephros.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866318000343 [Primary]
GS1	10866318000340 [Package]; Contains: 00866318000343; Package: Single box, one part [1 Units]; In Commercial Distribution
GS1	20866318000347 [Package]; Contains: 10866318000340; Package: box of 30 single box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161467

FDA Product Code

• NHV: System, Water Purification, General Medical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-15
• Device Publish Date: 2017-12-31

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