Catalog Number

-

Brand Name

Vistarmed

Version/Model Number

V1026C-MQ

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152465

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

9a49d491-a244-409a-a63e-e85e938870ec

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-