HydraGuard 10” UltraFilter - Flushable

GUDID 20866318000330

The HydraGuard 10” UltraFilter - Fin is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for washing and drinking, the filter aids in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands Contraindications: Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.

NEPHROS, INC.

Particulate water purification filter

• Primary Device ID: 20866318000330
• NIH Device Record Key: 9ad709d2-0c0b-49af-bbbd-1d5cd8a76719
• Commercial Distribution Discontinuation: 2017-12-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HydraGuard 10” UltraFilter - Flushable
• Version Model Number: 70-0111F
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866318000336 [Primary]
GS1	10866318000333 [Package]; Contains: 00866318000336; Package: one part per BOX [1 Units]; Discontinued: 2017-12-18; Not in Commercial Distribution
GS1	20866318000330 [Package]; Contains: 10866318000333; Package: 30 boxes for CARTON [30 Units]; Discontinued: 2017-12-18; Not 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: 2017-07-18

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