Catalog Number

-

Brand Name

CDI™ Shunt Sensor

Version/Model Number

CDI510H

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

K133658,K133658

Product Code

DRY

Product Code Name

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Public Device Record Key

4a646dfb-f506-41d0-aa0c-5d1864b99a2a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2016

Package DI Number

50699753160762

Quantity per Package

20

Contains DI Package

00699753160767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

20 Piece Case