Catalog Number

-

Brand Name

Vitalcontrol

Version/Model Number

SFT77

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

0623cbdc-75e3-4367-82f7-d5ea4fe37248

Public Version Date

February 25, 2019

Public Version Number

2

DI Record Publish Date

October 22, 2018

Package DI Number

10853879007970

Quantity per Package

10

Contains DI Package

00853879007973

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack