Catalog Number

-

Brand Name

OxyJet

Version/Model Number

1

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

c878202d-d80f-49b0-ac17-102ddcf393d4

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 23, 2019

Package DI Number

20851232007114

Quantity per Package

10

Contains DI Package

10851232007704

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE