Catalog Number

-

Brand Name

ProCheck

Version/Model Number

IR1DY1-1-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

9b198710-1971-42af-b3d8-cc2f635a1d7e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 27, 2017

Package DI Number

20642632014440

Quantity per Package

72

Contains DI Package

10642632014443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton packing