Catalog Number

AR3109

Brand Name

American Red Cross

Version/Model Number

FC-IR101

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

971d06b9-69a0-4d99-a0a6-9896c08cbdf8

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 24, 2021

Package DI Number

84617503109127

Quantity per Package

12

Contains DI Package

84617503109011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton