Catalog Number

-

Brand Name

Intersept®

Version/Model Number

6106

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

K800178,K800178

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

c5877255-2339-48d2-b5f6-1e0027931c29

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20673978555144

Quantity per Package

20

Contains DI Package

00673978555140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK