Catalog Number

-

Brand Name

Vibralung Patient Change Kit

Version/Model Number

9640

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

abd265a1-e21c-44dc-b376-bc2e5c57455c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 15, 2016

Package DI Number

10709078001373

Quantity per Package

25

Contains DI Package

00709078001376

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-