Catalog Number

-

Brand Name

Launch

Version/Model Number

TAE03-16S

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181967

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

2bab3621-90ca-4db6-841f-32be01cac4bf

Public Version Date

September 10, 2019

Public Version Number

1

DI Record Publish Date

September 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-