Catalog Number

02.0031

Brand Name

MesaLabs

Version/Model Number

02.0031

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JCC

Product Code Name

Ph Buffer

Public Device Record Key

d87b45fe-8ddb-44c9-adb6-7f267d2aefcd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 02, 2015

Package DI Number

M9850202101

Quantity per Package

6

Contains DI Package

M9850200310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton