Catalog Number

-

Brand Name

N/A

Version/Model Number

1341030S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2021

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)

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

09ce79b6-9dd9-4e3f-be11-a5e7a07ffd0b

Public Version Date

February 07, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

05030267083749

Quantity per Package

50

Contains DI Package

05030267083732

Package Discontinue Date

September 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-