Catalog Number

042510601A

Brand Name

Monitoring Kit

Version/Model Number

042510601A

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

K780271,K780271

Product Code

DTL

Product Code Name

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Public Device Record Key

a60ec7f0-853a-4861-b1bf-5ca11599ca2a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

20886333201888

Quantity per Package

25

Contains DI Package

00886333201884

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box