Catalog Number

194320D

Brand Name

Left Heart Kit

Version/Model Number

194320D

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

786b43f9-9c14-4455-a2f9-473c32e8071e

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

20886333207750

Quantity per Package

20

Contains DI Package

00886333207756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box