Catalog Number

-

Brand Name

Medisystems Hemodialysis Blood Tubing Sets

Version/Model Number

B3-4630M4705

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 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"

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

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Public Device Record Key

e2f6fd3b-2ef9-40ba-b4ca-73b9b51b3fe8

Public Version Date

September 29, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

M535B34630M47055

Quantity per Package

12

Contains DI Package

M535B34630M47050

Package Discontinue Date

September 28, 2020

Package Status

Not in Commercial Distribution

Package Type

-