Catalog Number

-

Brand Name

N/A

Version/Model Number

1745030

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092409,K092409

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

0243628b-679d-4353-9cac-a9715910d275

Public Version Date

February 07, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

05030267094479

Quantity per Package

40

Contains DI Package

05030267094462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-