Catalog Number

RMS23412

Brand Name

Split Cath® III

Version/Model Number

RMS23412

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"

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

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

c74d985c-c91a-4242-bb65-a7f7ed39399c

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2020

Package DI Number

50884908158064

Quantity per Package

10

Contains DI Package

00884908158069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box