Catalog Number

CA400-HV

Brand Name

Aria HV Valve insert

Version/Model Number

CA400-HV

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ISP

Product Code Name

Valve, Prosthesis

Public Device Record Key

34201b6b-e8d1-4807-bec8-bff8df4b3c78

Public Version Date

August 12, 2021

Public Version Number

2

DI Record Publish Date

December 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-