Catalog Number

-

Brand Name

ECO HMEF

Version/Model Number

4331/01BAUA001/0001

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"

-

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

7bbd17a6-0017-484e-9c47-b01ef41f0e02

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

35060120950100

Quantity per Package

200

Contains DI Package

25060120950103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer box