Catalog Number

CV000307

Brand Name

Medistim System Activation Card

Version/Model Number

CV000307

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040228,K040228

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Public Device Record Key

849c6296-38d9-4fe4-8ee1-c9dddf9938ba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

7070554104137

Quantity per Package

5

Contains DI Package

07070554104120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-