Catalog Number

02.0014

Brand Name

MesaLabs

Version/Model Number

02.0014

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033330,K033330

Product Code

FKH

Product Code Name

Solution-Test Standard-Conductivity, Dialysis

Public Device Record Key

66aa4c63-57aa-4403-9ed5-c68f296f1785

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 02, 2015

Package DI Number

M9850205001

Quantity per Package

12

Contains DI Package

M9850200140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton