Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

DMT-4333

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

4f52da26-9ea2-4fee-b740-f3180e74e811

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

May 30, 2018

Package DI Number

60368001110022

Quantity per Package

30

Contains DI Package

20368001110024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case