Catalog Number

-

Brand Name

HEPA Ventilation Filter

Version/Model Number

4020/03ABMA001/0001

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K033008,K033008

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

689bb3a2-6a59-4116-876b-9ec42fee2454

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

June 26, 2020

Package DI Number

15060120957747

Quantity per Package

50

Contains DI Package

05060120957740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton