Catalog Number

-

Brand Name

ECO Maxi filter

Version/Model Number

4222/701BSSA

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K033008,K033008,K033008

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

819f5569-e64a-444a-9ae4-5455e6b09f49

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

January 31, 2019

Package DI Number

25060511621780

Quantity per Package

50

Contains DI Package

15060511621783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-