Catalog Number

Type: SBM46/1

Brand Name

Vitalcontrol

Version/Model Number

SBM46

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"

Yes

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

5113ca07-e060-47e6-bfd7-ecb7fff8126d

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

January 09, 2017

Package DI Number

10852547004969

Quantity per Package

4

Contains DI Package

00852547004962

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case