Catalog Number

-

Brand Name

MedicaLyte

Version/Model Number

BC-200

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

K012547,K012547

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

cb559d41-ced9-4215-9eb7-8be26aa08916

Public Version Date

August 27, 2018

Public Version Number

1

DI Record Publish Date

July 25, 2018

Package DI Number

30817411021095

Quantity per Package

4

Contains DI Package

00817411021094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-