Catalog Number

-

Brand Name

Apex

Version/Model Number

70031

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

9e0a7e00-8a82-4861-9669-9eb3305e8bcb

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

October 06, 2016

Package DI Number

30076855700311

Quantity per Package

56

Contains DI Package

00076855700310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA