Catalog Number

43009

Brand Name

CV Scavenging Circuit, Basic Replacement

Version/Model Number

43009

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 10, 2199

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

-

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

K033503

Product Code

CBN

Product Code Name

Apparatus, Gas-Scavenging

Public Device Record Key

2c956161-676d-492b-a6aa-136281343a81

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-