Catalog Number

-

Brand Name

BISON

Version/Model Number

Probe Covers

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

Yes

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

78360ed6-c51f-439c-9b18-f76b716b6c1c

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 13, 2019

Package DI Number

10811787035027

Quantity per Package

2250

Contains DI Package

00811787031305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-