Catalog Number

-

Brand Name

Split Cath® III

Version/Model Number

AAC23613

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

d3fff98a-da22-4889-9c36-e5d2d71054e7

Public Version Date

June 23, 2021

Public Version Number

6

DI Record Publish Date

October 22, 2015

Package DI Number

50884908000974

Quantity per Package

10

Contains DI Package

00884908000979

Package Discontinue Date

March 25, 2021

Package Status

Not in Commercial Distribution

Package Type

box