Catalog Number

-

Brand Name

Eocene

Version/Model Number

EHS-SDTH

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140681

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

5c3407d4-9104-48bc-82ea-813ec8e89b16

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

April 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-