Catalog Number

CM2010

Brand Name

CardioMEMS™

Version/Model Number

Guidewire

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

-

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

856398c9-b438-4a22-93df-e26fc809750f

Public Version Date

April 05, 2018

Public Version Number

3

DI Record Publish Date

July 15, 2015

Package DI Number

15414734509562

Quantity per Package

5

Contains DI Package

05414734509565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-