Catalog Number

500-0100-02

Brand Name

VitalSense

Version/Model Number

VITALSENSE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033534

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

b9df3132-cc35-4f36-ac74-ee5ad91f93a3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-