Vibralung Patient Kit - 1 each: Standard Y Adapter, Aerosol Y-Adapter, - WESTMED, INC.

Duns Number:092673953

Device Description: 1 each: Standard Y Adapter, Aerosol Y-Adapter, Hand-held Transducer (HHT) assembly with sc 1 each: Standard Y Adapter, Aerosol Y-Adapter, Hand-held Transducer (HHT) assembly with screw-on Cone pre-attached, and disposable ear plugs.

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More Product Details

Catalog Number

-

Brand Name

Vibralung Patient Kit

Version/Model Number

9600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

BYI

Product Code Name

Percussor, Powered-Electric

Device Record Status

Public Device Record Key

61c20187-a756-4992-8b4c-e23414e4efce

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 15, 2016

Additional Identifiers

Package DI Number

10709078001366

Quantity per Package

1

Contains DI Package

00709078001369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"WESTMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 746
2 A medical device with a moderate to high risk that requires special controls. 320