Catalog Number

-

Brand Name

Vistarmed

Version/Model Number

VD-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 22, 2022

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152468

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

4683d6be-6d61-4f6f-9555-6b8cb4121209

Public Version Date

March 02, 2022

Public Version Number

1

DI Record Publish Date

February 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-