Catalog Number

HEM-18

Brand Name

Self-Taking Blood Pressure Kit

Version/Model Number

HEM-18

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

-

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

K780715,K780715,K780715

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

c50b0085-cb5d-42f3-8436-c09a07aa1693

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10073796000186

Quantity per Package

12

Contains DI Package

00073796000189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton