S100 Handheld thread

GUDID 10896241002562

The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands.

NEPHROS, INC.

Legionella water purification filter, non-sterile

• Primary Device ID: 10896241002562
• NIH Device Record Key: e5d6718e-0848-4174-814c-bc1e2e479403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S100 Handheld thread
• Version Model Number: 70-0282
• 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	00896241002565 [Primary]
GS1	10896241002562 [Package]; Contains: 00896241002565; Package: Carton Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153084

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-09-14
• Device Publish Date: 2016-09-22

On-Brand Devices [S100 Handheld thread]

• 10896241002562: The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA qualit
• 10896241002579: The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA qualit