Catalog Number

-

Brand Name

iProvèn

Version/Model Number

TMT-215

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

K131243,K172795

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a26389c8-a153-484f-a3e9-231ae63b3316

Public Version Date

May 23, 2022

Public Version Number

5

DI Record Publish Date

January 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-