Catalog Number

-

Brand Name

Finicare

Version/Model Number

FC-IR1030

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181215

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

699ab870-8560-4f07-8a10-abdc0c9b9b88

Public Version Date

November 08, 2019

Public Version Number

1

DI Record Publish Date

October 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-