Catalog Number

-

Brand Name

TQE Plus Endotoxin 10" Filter Flat 222 Head

Version/Model Number

TQE0.005-10HP3E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161304,K161304,K161304

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Public Device Record Key

69ac3265-a05b-4211-8580-b59391d60ac7

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Package DI Number

10868277000447

Quantity per Package

1

Contains DI Package

00868277000440

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Filter Box