Catalog Number

-

Brand Name

BabyTemp by Baby Doppler

Version/Model Number

DuoSmart Thermometer

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

K140681,K140681,K140681

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

2184086f-949a-47eb-8a3d-f0861dfef866

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

May 28, 2020

Package DI Number

10628055787836

Quantity per Package

1

Contains DI Package

00628055787839

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Product Packaging