Catalog Number

-

Brand Name

Summer Infant

Version/Model Number

14514

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

3039242b-9c45-48cf-8fc5-351ae15c9f08

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 21, 2016

Package DI Number

20012914145146

Quantity per Package

24

Contains DI Package

10012914145149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master