Catalog Number

433EU

Brand Name

Adtemp™

Version/Model Number

433EU

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

8a5e924f-fc61-47c7-8bd9-a97b9c14a63c

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

August 21, 2020

Package DI Number

00634782899806

Quantity per Package

6

Contains DI Package

00634782098414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack