Catalog Number

-

Brand Name

Mesanfit

Version/Model Number

HTD8813C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 2020

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

53926d3c-f10f-4f46-8afd-d959feef122d

Public Version Date

April 28, 2021

Public Version Number

3

DI Record Publish Date

August 04, 2020

Package DI Number

17958909771661

Quantity per Package

40

Contains DI Package

07958909771664

Package Discontinue Date

August 10, 2020

Package Status

Not in Commercial Distribution

Package Type

-