Catalog Number

CUFF-210

Brand Name

VASOCUFF

Version/Model Number

CUFF-210

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

K152468,K152468

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

530aaf0a-329b-438e-b780-2f2f6ffbaaee

Public Version Date

July 14, 2021

Public Version Number

1

DI Record Publish Date

July 06, 2021

Package DI Number

00852785008739

Quantity per Package

8

Contains DI Package

00852785008685

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX