Catalog Number

-

Brand Name

MedicaLyte

Version/Model Number

BC+201

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,K012547

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

2839b754-9191-45ad-bfff-9f710a0a5f2f

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Package DI Number

10817411022821

Quantity per Package

4

Contains DI Package

00817411022824

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case