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

9cfd84b4-2637-406f-baf3-c0e0b9f1722c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 06, 2017

Package DI Number

30642632060208

Quantity per Package

144

Contains DI Package

20642632060201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton packing