Catalog Number

CM1010

Brand Name

CardioMEMS™

Version/Model Number

CM1010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MOM

Product Code Name

System, hemodynamic, implantable

Public Device Record Key

0563d051-25db-4d6c-9acc-0f51fe269102

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 29, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-