Catalog Number

-

Brand Name

fridababy

Version/Model Number

FB068

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2021

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"

Yes

For Single-Use

Yes

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

K182133,K182133

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

dc35193c-c5b5-430d-8881-9fb78bd38fa2

Public Version Date

March 01, 2021

Public Version Number

2

DI Record Publish Date

January 12, 2021

Package DI Number

20810028770618

Quantity per Package

12

Contains DI Package

00810028770614

Package Discontinue Date

October 14, 2020

Package Status

Not in Commercial Distribution

Package Type

-