S100 Handheld quick connect

GUDID 10896241002586

S100 Handheld quick connect and packaging information

NEPHROS, INC.

Legionella water purification filter, non-sterile

• Primary Device ID: 10896241002586
• NIH Device Record Key: c1a9b028-45a6-4f2d-b5d2-1e3108877652
• Commercial Distribution Discontinuation: 2021-09-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: S100 Handheld quick connect
• Version Model Number: 70-0287
• 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	00896241002589 [Primary]
GS1	10896241002586 [Package]; Contains: 00896241002589; Package: carton [6 Units]; Discontinued: 2021-09-16; Not 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: 2021-09-17
• Device Publish Date: 2016-09-22

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