Catalog Number

AT030718

Brand Name

Disposable Water Filter FILTRAY 2G

Version/Model Number

AT030718

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

K191563,K191563

Product Code

NHV

Product Code Name

System, Water Purification, General Medical Use

Public Device Record Key

3a69a082-13b9-4084-9d3c-7080f6e3ca23

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Package DI Number

03760279730431

Quantity per Package

10

Contains DI Package

03760279730073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box