Catalog Number

03758

Brand Name

Hokanson

Version/Model Number

DP2.0™

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)

Yes

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

K932851,K932851,K932851,K932851

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

0db90117-80dc-4d5c-808a-9fc7307b6881

Public Version Date

October 05, 2020

Public Version Number

4

DI Record Publish Date

July 18, 2017

Package DI Number

00817065022324

Quantity per Package

25

Contains DI Package

00817065022300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box