Catalog Number

-

Brand Name

Hepa Filter

Version/Model Number

10-55374

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

K132709,K132709

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

6178df75-009c-42d4-9e9f-b79c1161319f

Public Version Date

January 31, 2022

Public Version Number

2

DI Record Publish Date

April 19, 2021

Package DI Number

30641043553743

Quantity per Package

50

Contains DI Package

10641043553749

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-