Catalog Number

-

Brand Name

Medisystems Dialysis Priming Set

Version/Model Number

M4-9440

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 19, 2020

Issuing Agency

In HIBCC

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"

-

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

KOC

Product Code Name

Accessories, Blood Circuit, Hemodialysis

Public Device Record Key

fb8c94d1-cb1a-4d1e-801d-1ad46d5d8dd0

Public Version Date

October 20, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

M535M494405

Quantity per Package

200

Contains DI Package

M535M494400

Package Discontinue Date

October 19, 2020

Package Status

Not in Commercial Distribution

Package Type

-