Catalog Number

Y7916

Brand Name

American Red Cross

Version/Model Number

Y7916

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

518a2650-d194-43e1-a1cb-4674c2fc3103

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Package DI Number

B268Y79161

Quantity per Package

1

Contains DI Package

B268Y79160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Retail