Catalog Number

-

Brand Name

FILTA-THERM HMEF WITH LUER PORT

Version/Model Number

1941000

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

-

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

844f9979-5f36-48ff-897a-9604a409242e

Public Version Date

February 07, 2022

Public Version Number

3

DI Record Publish Date

September 29, 2021

Package DI Number

05030267004386

Quantity per Package

70

Contains DI Package

05030267056569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-