Catalog Number

-

Brand Name

Family Wellness

Version/Model Number

916061

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

6604ba5e-6941-4977-96ed-a272402d1ed5

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 07, 2020

Package DI Number

30032251627621

Quantity per Package

3

Contains DI Package

00032251627620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Intermediate