Catalog Number

-

Brand Name

APEX

Version/Model Number

70135

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

b48786e2-ffde-4aee-9174-5bba8376913d

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

50076855701350

Quantity per Package

2

Contains DI Package

30076855701356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA