Catalog Number

57003

Brand Name

Pulse Pro Quick Start Guide

Version/Model Number

Pulse Pro Quick Start Guide

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

K160608

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

7ee11d10-c1b6-4508-8b6a-d0487970f724

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-