Catalog Number

-

Brand Name

iProvèn

Version/Model Number

DMT-316w

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

K131243,K172795

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

3de18079-7a04-483f-8a6b-3bd0632cdce8

Public Version Date

May 23, 2022

Public Version Number

5

DI Record Publish Date

August 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-