Catalog Number

-

Brand Name

The Vest®System

Version/Model Number

P300630000

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYI

Product Code Name

PERCUSSOR, POWERED-ELECTRIC

Public Device Record Key

c1e58d3a-b5f8-4fa7-a57c-0e755610daa0

Public Version Date

January 18, 2021

Public Version Number

4

DI Record Publish Date

September 17, 2016

Package DI Number

10887761997209

Quantity per Package

5

Contains DI Package

00887761997202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-