Catalog Number

-

Brand Name

Mon-a-Therm

Version/Model Number

502-0400A

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K895875,K895875

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

d2b33672-9127-408a-9f00-a7a56a6c5786

Public Version Date

July 07, 2022

Public Version Number

4

DI Record Publish Date

February 21, 2019

Package DI Number

10884521706392

Quantity per Package

40

Contains DI Package

10884521169272

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE