Catalog Number

768-641MHOP

Brand Name

Hopkins

Version/Model Number

768-641MHOP

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

5a9d5bbb-93d3-4a89-805a-2c6afd117389

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 21, 2017

Package DI Number

00634782534615

Quantity per Package

12

Contains DI Package

00634782034764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case