Catalog Number

-

Brand Name

Procheck

Version/Model Number

MT16K1-PRO

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

bd0c5b15-e32a-4ea0-b3c4-85dd310867ca

Public Version Date

September 03, 2020

Public Version Number

3

DI Record Publish Date

October 24, 2016

Package DI Number

10642632802132

Quantity per Package

24

Contains DI Package

00642632018932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Display Box