Catalog Number

-

Brand Name

Revitality

Version/Model Number

NEB-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K171549,K171549

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

ae579be7-2285-4f7d-ad4a-736fa297e64d

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

16971331400351

Quantity per Package

20

Contains DI Package

06971331400347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box