Catalog Number

PD3103

Brand Name

Lifemed Acute Tenckhoff Peritoneal Catheter

Version/Model Number

PD3103

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

FKO

Product Code Name

Catheter, Peritoneal Dialysis, Single Use

Public Device Record Key

8a333523-9768-4296-ab0c-bbc14d186252

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2015

Package DI Number

10852250006014

Quantity per Package

2

Contains DI Package

00852250006017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box