Catalog Number

-

Brand Name

Summer Infant

Version/Model Number

14464

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

-

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

75de12d6-4ea2-4b78-9de5-48a2892245b0

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

October 21, 2016

Package DI Number

10012914144647

Quantity per Package

3

Contains DI Package

00012914144640

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner