Catalog Number

-

Brand Name

 PRESTIGE

Version/Model Number

HM-35

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

K093831,K093831

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

d59c44fb-d281-49bb-ba06-593414cc6c79

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

February 27, 2019

Package DI Number

14719872483257

Quantity per Package

12

Contains DI Package

04719872483250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-