Catalog Number

-

Brand Name

Vistarmed

Version/Model Number

V0122C-MQMF

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)

-

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

d3d13463-7930-4ca5-9f10-d437dd7e15ae

Public Version Date

August 28, 2020

Public Version Number

1

DI Record Publish Date

August 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-