Catalog Number

-

Brand Name

CLEAR-THERM MICRO HMEF L/PORT

Version/Model Number

1441000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032322,K032322,K032322

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

70966b34-6e6e-4c0d-8864-8f909a55456c

Public Version Date

February 07, 2022

Public Version Number

3

DI Record Publish Date

October 04, 2021

Package DI Number

05030267038312

Quantity per Package

20

Contains DI Package

05030267052523

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-