TQE Plus Endotoxin 10" Filter Flat 222 Head

GUDID 10868277000416

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

NEPHROS, INC.

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Primary Device ID10868277000416
NIH Device Record Keyfbeb2ecb-ae47-4bcd-b198-062e1cd527b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTQE Plus Endotoxin 10" Filter Flat 222 Head
Version Model NumberTQE0.005-10P3E
Company DUNS120664557
Company NameNEPHROS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100868277000419 [Primary]
GS110868277000416 [Package]
Contains: 00868277000419
Package: 1 part per box [1 Units]
In Commercial Distribution
GS120868277000413 [Package]
Package: 30 boxes per Carton [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10868277000416]

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[10868277000416]

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[10868277000416]

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[10868277000416]

Liquid Chemical

[10868277000416]

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[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

Liquid Chemical

[10868277000416]

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[10868277000416]

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Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-08-24
Device Publish Date2017-12-21

On-Brand Devices [TQE Plus Endotoxin 10" Filter Flat 222 Head]

02086827700048The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox
10868277000416The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox
10868277000447The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox
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