Catalog Number

Y7057

Brand Name

American Red Cross

Version/Model Number

Y7054, Y7057

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

b7842ee2-253b-40aa-8fa3-8e8f8f1006fa

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

December 29, 2017

Package DI Number

B268Y7054Y70579

Quantity per Package

12

Contains DI Package

B268Y7054Y70573

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master