Catalog Number

5294780

Brand Name

LEADER

Version/Model Number

5294780

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

K032362,K032362,K032362

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

e8d05e04-00ea-4f5d-a4fa-d8b7cbd81cf3

Public Version Date

July 02, 2021

Public Version Number

4

DI Record Publish Date

April 14, 2017

Package DI Number

50096295130084

Quantity per Package

12

Contains DI Package

30096295130080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE