Catalog Number

P70100

Brand Name

PEGASUS

Version/Model Number

P70100

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K880473,K880473

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

63c01dd9-9f3c-4f06-8ba9-684ecf7fc6db

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Package DI Number

00612223701000

Quantity per Package

10

Contains DI Package

00612223701017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS