Catalog Number

81-101400

Brand Name

DeRoyal

Version/Model Number

81-101400

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"

Yes

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

b0c594ea-985e-4793-97ed-557b815f56f9

Public Version Date

July 20, 2021

Public Version Number

1

DI Record Publish Date

July 12, 2021

Package DI Number

50749756140268

Quantity per Package

20

Contains DI Package

00749756140263

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case