Catalog Number

22-000910-10

Brand Name

BIOTRANS™ Pressure Monitoring Kits

Version/Model Number

CCF-LEFT HEART SET-CC91010

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

DRS

Product Code Name

Transducer, Blood-Pressure, Extravascular

Public Device Record Key

7bf77055-7065-48b8-b63b-a32fd32aa276

Public Version Date

June 30, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

98888893311152

Quantity per Package

9

Contains DI Package

28888893311153

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CTN