Catalog Number

-

Brand Name

Actherm

Version/Model Number

Probe Cover

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)

-

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

77736ba0-f51e-4c3a-82a5-9cbd77a4d9f2

Public Version Date

January 13, 2020

Public Version Number

2

DI Record Publish Date

June 14, 2019

Package DI Number

06972325560313

Quantity per Package

200

Contains DI Package

06972325561266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-