Catalog Number

Y7054

Brand Name

American Red Cross

Version/Model Number

Y7054

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

f6b39de3-cdae-46cb-a87f-786590dca33c

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

December 20, 2017

Package DI Number

B268Y70549

Quantity per Package

24

Contains DI Package

B268Y70544

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master