AeroChamber Plus® Flow-Vu® - Monaghan Medical Corporation

Duns Number:056332380

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More Product Details

Catalog Number

-

Brand Name

AeroChamber Plus® Flow-Vu®

Version/Model Number

aVHC, Mouthpiece, Allergan, Single

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

K112010

Product Code Details

Product Code

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Device Record Status

Public Device Record Key

3a78a312-4722-4351-8ae6-c7b21379b2fd

Public Version Date

September 09, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MONAGHAN MEDICAL CORPORATION" 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. 39