Catalog Number

CP00003

Brand Name

PowerPort isp Implantable Port

Version/Model Number

CP00003

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

-

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Public Device Record Key

7e9304e8-47f2-4996-962d-8b6c8f964727

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

October 01, 2015

Package DI Number

10801741101066

Quantity per Package

5

Contains DI Package

00801741101069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA