Micro-Vent - Micro-Vent Radioaerosol System - BIODEX MEDICAL SYSTEMS, INC.

Duns Number:043833813

Device Description: Micro-Vent Radioaerosol System

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

177-107

Brand Name

Micro-Vent

Version/Model Number

177-107

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K904717,K904717,K904717,K904717

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

080788a2-d6ba-4c55-8221-14f4d6d3124a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 16, 2016

Additional Identifiers

Package DI Number

30718175001104

Quantity per Package

25

Contains DI Package

00718175001073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BIODEX MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 193
2 A medical device with a moderate to high risk that requires special controls. 52