Catalog Number

CT-VS-SM, CT-VS-CM, CT-VS-HM

Brand Name

VitalStream

Version/Model Number

CT5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

-

Product Code

DXN

Product Code Name

System, measurement, blood-pressure, non-invasive

Public Device Record Key

1916b7dc-ee03-4f23-947e-20ded8005083

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-