Catalog Number

-

Brand Name

FLYp

Version/Model Number

0002

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

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

3b628db4-dcbc-43df-900b-579c93a38263

Public Version Date

April 16, 2021

Public Version Number

1

DI Record Publish Date

April 08, 2021

Package DI Number

10869112000165

Quantity per Package

6

Contains DI Package

00869112000168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack