Catalog Number

-

Brand Name

Actherm

Version/Model Number

3230

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

K070028,K070028,K070028,K070028,K070028

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a7700ff4-5ac2-4b6d-bb89-a692b735d59c

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 14, 2019

Package DI Number

06972325561198

Quantity per Package

600

Contains DI Package

06972325560214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-