Catalog Number

-

Brand Name

Vibralung Patient Kit with Circulair II Model 0295

Version/Model Number

9605-10

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

6af31c03-16ed-4182-b5dc-12e7a749911d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 15, 2016

Package DI Number

10709078001502

Quantity per Package

1

Contains DI Package

00709078001505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-