TQE Plus Endotoxin 30" Filter Flat 222 Head

GUDID 20868277000437

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: 20868277000437
• NIH Device Record Key: 93b39d0f-a476-4c3a-8ed4-792be28be137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TQE Plus Endotoxin 30" Filter Flat 222 Head
• Version Model Number: TQE0.005-30P3E
• 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	00868277000433 [Primary]
GS1	10868277000430 [Package]; Contains: 00868277000433; Package: 1 part per box [1 Units]; In Commercial Distribution
GS1	20868277000437 [Package]; Contains: 10868277000430; 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

[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

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[20868277000437]

Liquid Chemical

[20868277000437]

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[20868277000437]

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[20868277000437]

Liquid Chemical

[20868277000437]

Liquid Chemical

[20868277000437]

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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 30" Filter Flat 222 Head]

• 02086827700062: The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox
• 20868277000437: The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox