Catalog Number

-

Brand Name

Safety 1st

Version/Model Number

TH104

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

K121428,K121428,K121428

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

e3d441b8-6e86-4e04-8625-96f34d83483c

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

December 04, 2018

Package DI Number

20884392626024

Quantity per Package

6

Contains DI Package

00884392626020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master