Catalog Number

-

Brand Name

CARETALK

Version/Model Number

TH5001N

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161735,K161735

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

3a5a5941-f057-49f1-95e3-674e52145120

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

March 19, 2020

Package DI Number

16926408700209

Quantity per Package

10

Contains DI Package

06926408700202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box