Catalog Number

-

Brand Name

Polysite

Version/Model Number

4018C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 22, 2017

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"

-

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

K122834

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Public Device Record Key

c05bfadd-5833-4db0-9fd3-4cab56a15c64

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

October 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-