DeVilbiss - Vacu-Aide Homecare Suction Unit, Latin America - DEVILBISS HEALTHCARE LLC

Duns Number:962175894

Device Description: Vacu-Aide Homecare Suction Unit, Latin America

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More Product Details

Catalog Number

7305D-LA

Brand Name

DeVilbiss

Version/Model Number

7305D-LA

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"

-

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

-

Product Code Details

Product Code

JCX

Product Code Name

Apparatus, Suction, Ward Use, Portable, Ac-Powered

Device Record Status

Public Device Record Key

8d45d930-05df-4517-ab6d-3d210f5ae66d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEVILBISS HEALTHCARE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 197