Catalog Number

AL6500500

Brand Name

Baby Doppler

Version/Model Number

BabyTemp 1 Sec 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

K180207

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

0b36143a-bf5a-4d3e-a6be-a310e881c391

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

May 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-