Catalog Number

-

Brand Name

Smart Connector

Version/Model Number

Smart Connector

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

K981613,K981613

Product Code

DTL

Product Code Name

ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Public Device Record Key

1be94244-6c13-4972-85c0-46986cc2708b

Public Version Date

August 15, 2018

Public Version Number

4

DI Record Publish Date

May 19, 2015

Package DI Number

10803622124959

Quantity per Package

10

Contains DI Package

00803622124952

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE