Catalog Number

-

Brand Name

COMPER

Version/Model Number

IR-FT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K191668,K191668,K191668,K191668,K191668

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

adb82991-0f1c-45b2-967b-3eb870d1b244

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

November 12, 2019

Package DI Number

26970528391103

Quantity per Package

52

Contains DI Package

06970528391109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-