Catalog Number

-

Brand Name

Prime Alert

Version/Model Number

PA001

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

K130563,K130563

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

c0210808-dcf1-4849-9333-a51837587539

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

February 27, 2019

Package DI Number

14719872483264

Quantity per Package

12

Contains DI Package

04719872483267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-