Catalog Number

CV000448

Brand Name

Medistim System Activation Card

Version/Model Number

CV000448

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102595,K102595

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Public Device Record Key

4061ddbe-6df6-4210-928b-99fc585c1351

Public Version Date

October 19, 2021

Public Version Number

1

DI Record Publish Date

October 11, 2021

Package DI Number

07070554104878

Quantity per Package

5

Contains DI Package

07070554104830

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-