Catalog Number

HEM-907-CS19

Brand Name

Small Cuff, Bladder for Hem-907

Version/Model Number

HEM-907-CS19

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

K032305,K032305

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

a6e4fea4-6c79-4fd8-893f-85d1a166c2f5

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10073796907010

Quantity per Package

20

Contains DI Package

00073796907013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case