Catalog Number

-

Brand Name

BISON

Version/Model Number

DMT-437

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

98f587e1-f1e5-4f6b-9a5a-4d67d70d48db

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 13, 2019

Package DI Number

10811787031449

Quantity per Package

300

Contains DI Package

00811787031442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-