Catalog Number

JXB-178

Brand Name

Berrcom

Version/Model Number

09-178

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

c410440c-8703-43ff-9e27-5298cc98fb56

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

April 23, 2020

Package DI Number

10845717009871

Quantity per Package

40

Contains DI Package

00845717009874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton