Catalog Number

TBC

Brand Name

"X" SERIES PD CATHETER"X" SERIES PD CATHETER

Version/Model Number

TBC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

FJS

Product Code Name

Catheter, peritoneal, long-term indwelling

Public Device Record Key

9a839702-6694-4ec0-9f55-bd3f0cb79dec

Public Version Date

February 04, 2021

Public Version Number

2

DI Record Publish Date

July 10, 2019

Package DI Number

50884908097097

Quantity per Package

4

Contains DI Package

30884908097093

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box