Catalog Number

-

Brand Name

Emay

Version/Model Number

WT2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 03, 2022

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

K152739

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a89108d0-ab9a-4ec7-9d41-9f781070c628

Public Version Date

August 03, 2022

Public Version Number

4

DI Record Publish Date

August 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-