Catalog Number

CUFF-200

Brand Name

VASOCUFF

Version/Model Number

CUFF-200

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

7dd621a4-35d6-421b-a7c4-395bccc048a3

Public Version Date

July 14, 2021

Public Version Number

1

DI Record Publish Date

July 06, 2021

Package DI Number

00852785008722

Quantity per Package

8

Contains DI Package

00852785008678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX