Catalog Number

P6050

Brand Name

PEGASUS

Version/Model Number

P6050

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

Yes

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

BYF

Product Code Name

Mask, Oxygen, Low Concentration, Venturi

Public Device Record Key

7b01dc29-d77a-484c-8102-17667089920a

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

September 17, 2021

Package DI Number

00612223060503

Quantity per Package

20

Contains DI Package

00612223060510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS