Catalog Number

CUFF-240D

Brand Name

VASOCUFF

Version/Model Number

CUFF-240D

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152465,K152465

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

4a576049-bf7e-449e-a661-585e12cec9ea

Public Version Date

July 14, 2021

Public Version Number

1

DI Record Publish Date

July 06, 2021

Package DI Number

00852785008777

Quantity per Package

10

Contains DI Package

00852785008715

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX