Catalog Number

PD6101

Brand Name

Lifemed Lifecoil Chronic Peritoneal Catheter

Version/Model Number

PD6101

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

FKX

Product Code Name

System, Peritoneal, Automatic Delivery

Public Device Record Key

b3c70ea3-3b80-49fe-a71a-7eaa671c176c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2015

Package DI Number

10852250006021

Quantity per Package

2

Contains DI Package

00852250006024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box