Catalog Number

-

Brand Name

THERAPlus

Version/Model Number

11012340K

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102718

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

c8092c64-817f-419b-be0d-9522d661e1a3

Public Version Date

September 28, 2021

Public Version Number

2

DI Record Publish Date

July 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-