Catalog Number

5427802

Brand Name

LEADER

Version/Model Number

5427802

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

4b307359-addc-41b4-868a-08dd5180e9cb

Public Version Date

December 06, 2021

Public Version Number

3

DI Record Publish Date

May 01, 2019

Package DI Number

30096295134156

Quantity per Package

1

Contains DI Package

00096295134155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX