DSU-H Thread (Polyproplyene)

GUDID 10896241002104

The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapure water for washing and drinking, the filters aid 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.

NEPHROS, INC.

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• Primary Device ID: 10896241002104
• NIH Device Record Key: 4dc5ebf9-8c5b-4ad3-ad9d-3118518df93e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSU-H Thread (Polyproplyene)
• Version Model Number: 70-0286P
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896241002107 [Primary]
GS1	10896241002104 [Package]; Contains: 00896241002107; Package: Filter Box [1 Units]; In Commercial Distribution
GS1	20896241002101 [Package]; Package: Carton Box [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141731

FDA Product Code

• NHV: System, Water Purification, General Medical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-21
• Device Publish Date: 2022-03-11

Devices Manufactured by NEPHROS, INC.

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• 10896241002104 - DSU-H Thread (Polyproplyene): 2022-03-21The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapure water for washing and drinking, the filters aid 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.
• 10896241002104 - DSU-H Thread (Polyproplyene): 2022-03-21 The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
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