Catalog Number

DT-103

Brand Name

A&D Medical

Version/Model Number

DT-103

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)

Yes

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

434adb5f-ce93-492d-a6f3-e4cef2888762

Public Version Date

August 26, 2019

Public Version Number

1

DI Record Publish Date

August 16, 2019

Package DI Number

10093764603119

Quantity per Package

20

Contains DI Package

00093764603112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box