Catalog Number

-

Brand Name

SPLIT CATH® III

Version/Model Number

AAC23619

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 25, 2021

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

6410ffea-091e-4e0b-adb3-1d43ab701d64

Public Version Date

June 22, 2021

Public Version Number

6

DI Record Publish Date

April 29, 2016

Package DI Number

50884908001032

Quantity per Package

10

Contains DI Package

00884908001037

Package Discontinue Date

March 25, 2021

Package Status

Not in Commercial Distribution

Package Type

box