Catalog Number

HMEF711C

Brand Name

HME

Version/Model Number

HMEF711C

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"

-

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

-

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

255baa23-80c3-4088-b18b-c72199188001

Public Version Date

October 12, 2021

Public Version Number

4

DI Record Publish Date

April 17, 2020

Package DI Number

10850014574472

Quantity per Package

50

Contains DI Package

00850014574499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box