Catalog Number

-

Brand Name

MedicaLyte

Version/Model Number

DB-100-2.5

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

K131202,K131202

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Public Device Record Key

f383a669-1e79-4ed1-8d32-917eccbacae2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 23, 2017

Package DI Number

10817411020278

Quantity per Package

20

Contains DI Package

00817411020271

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-