TQE Plus Endotoxin 20" Filter Flat 222 Head

GUDID 10868277000423

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.

NEPHROS, INC.

Peritoneal dialysis system dialysate filter

• Primary Device ID: 10868277000423
• NIH Device Record Key: 2a9bf5ba-3fe9-40ad-96d3-e6a4626dd1f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TQE Plus Endotoxin 20" Filter Flat 222 Head
• Version Model Number: TQE0.005-20P3E
• 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: true
• 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	00868277000426 [Primary]
GS1	10868277000423 [Package]; Contains: 00868277000426; Package: 1 part per box [1 Units]; In Commercial Distribution
GS1	20868277000420 [Package]; Package: 15 boxes per carton [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161304

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

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

[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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[10868277000423]

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Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-08-24
• Device Publish Date: 2017-12-21

On-Brand Devices [TQE Plus Endotoxin 20" Filter Flat 222 Head]

• 01086827700056: The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox
• 10868277000423: The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox
• 10868277000454: The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox