Catalog Number

PD3101

Brand Name

Lifemed Chronic Tenckhoff Peritoneal Catheter

Version/Model Number

PD3101

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

-

Product Code

FJS

Product Code Name

Catheter, Peritoneal, Long-Term Indwelling

Public Device Record Key

a6272dcd-1f76-445a-9bdf-2e0fce848157

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2015

Package DI Number

10852250006007

Quantity per Package

2

Contains DI Package

00852250006000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box