Catalog Number

-

Brand Name

Polysite

Version/Model Number

4018C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

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

K122834,K122834

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Public Device Record Key

aacffea7-d8d2-4cbe-8bf7-04fa37173079

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

March 16, 2017

Package DI Number

13661234017659

Quantity per Package

1

Contains DI Package

03661234017652

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-