Catalog Number

-

Brand Name

Actherm

Version/Model Number

2020+Ex

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

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

2988ddf3-8afc-4768-80ff-f086d609b6f0

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 14, 2019

Package DI Number

06972325561068

Quantity per Package

600

Contains DI Package

06972325560085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-