Catalog Number

480007-BX-CC

Brand Name

RPC

Version/Model Number

480007-BX-CC

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

-

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

K090338

Product Code

MSY

Product Code Name

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Public Device Record Key

4dde5661-1f3e-4608-9ccb-923f12ba4520

Public Version Date

August 16, 2019

Public Version Number

4

DI Record Publish Date

March 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-