Catalog Number

P23000

Brand Name

PEGASUS

Version/Model Number

P23000

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K880473

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

2c1f54dd-547f-4929-b1a3-0e0a0a75a984

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-