Catalog Number

RMS23411

Brand Name

Split Cath® III

Version/Model Number

RMS23411

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

b0d05e15-0bba-47a2-a8fd-2a4d760678e5

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2020

Package DI Number

50884908158057

Quantity per Package

10

Contains DI Package

00884908158052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box