Catalog Number

-

Brand Name

CDI™ H/S Cuvette 1/2 x 1/2

Version/Model Number

6912

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,K133658

Product Code

DRY

Product Code Name

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

Public Device Record Key

d7cf3ba8-f72f-47a9-9ce1-ce5d3e591713

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2016

Package DI Number

50699753270140

Quantity per Package

6

Contains DI Package

30699753270146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

6 Piece Case