Catalog Number

-

Brand Name

BERRCOM

Version/Model Number

DT007

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

f58d07f6-6e6e-4bf1-80a9-3aacfdec9808

Public Version Date

April 29, 2021

Public Version Number

3

DI Record Publish Date

November 19, 2020

Package DI Number

16947656113269

Quantity per Package

200

Contains DI Package

06947656113262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cartoon