Catalog Number

-

Brand Name

Better Life Technologies

Version/Model Number

MT-108

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

K041516,K041516,K041516

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

0a8fab32-f79f-428b-9c03-e9559be28c00

Public Version Date

August 24, 2020

Public Version Number

1

DI Record Publish Date

August 15, 2020

Package DI Number

10850004257019

Quantity per Package

20

Contains DI Package

00850004257012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-