Catalog Number

-

Brand Name

Caroune

Version/Model Number

PC809

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

K172889,K172889

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

c5bbdb80-71ef-4340-b9fb-24f5fd751cad

Public Version Date

May 27, 2020

Public Version Number

2

DI Record Publish Date

October 31, 2019

Package DI Number

10840061480918

Quantity per Package

100

Contains DI Package

00840061480911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

corrugated container