Catalog Number

-

Brand Name

6130A

Version/Model Number

6130A

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

K090738,K090738,K090738,K090738,K090738,K090738

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

8ba3d53c-3da3-4de6-947c-a45c309941f4

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

January 15, 2020

Package DI Number

50850015328027

Quantity per Package

600

Contains DI Package

00850015328022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-