Catalog Number

-

Brand Name

Vibralung Treatment Control Unit

Version/Model Number

9500

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133057,K133057

Product Code

BYI

Product Code Name

Percussor, Powered-Electric

Public Device Record Key

0d61470e-b703-479a-89ce-a0e232a0b02b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 24, 2016

Package DI Number

10709078001335

Quantity per Package

1

Contains DI Package

00709078001338

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-