Catalog Number

-

Brand Name

SC+ Haemodialysis System

Version/Model Number

SC-14358

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"

-

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

2d2bc557-58b1-4f00-b002-2b7cec56c36b

Public Version Date

November 04, 2021

Public Version Number

2

DI Record Publish Date

June 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-