Catalog Number

CA100-MV

Brand Name

Aria Mini Valve

Version/Model Number

CA100-MV

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 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

-

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

ba26b2ce-f837-4fbe-a116-aa9e5fb861c2

Public Version Date

November 25, 2021

Public Version Number

2

DI Record Publish Date

August 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-