Catalog Number

-

Brand Name

NA

Version/Model Number

008958

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K945461,K945461

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

d9313d38-1168-4b2e-8697-d690d1c4a3dd

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 06, 2018

Package DI Number

20643169843060

Quantity per Package

5

Contains DI Package

00643169843066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK