Pro-Care Nebulizer Easy - Pro-Care Nebulizer Easy - ARISE MEDICAL LLC

Duns Number:081149273

Device Description: Pro-Care Nebulizer Easy

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


More Product Details

Catalog Number

-

Brand Name

Pro-Care Nebulizer Easy

Version/Model Number

Easy

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2018

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)

-

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

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

bc951a38-f6b3-440f-ba4e-d6e0c44b1594

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

December 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARISE MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 17