Catalog Number

-

Brand Name

Fridababy

Version/Model Number

61-067

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

660c83a7-e8fc-4082-8351-fa697427b6ce

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

Package DI Number

10851877006957

Quantity per Package

4

Contains DI Package

00851877006950

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Intermediate