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.

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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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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