Catalog Number

-

Brand Name

INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH 28% VENTURI VALVE, WHITE

Version/Model Number

1028085

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

Yes

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

abef6de3-bc4c-415a-91ab-7d0c5cdc0f8f

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 11, 2021

Package DI Number

05030267128037

Quantity per Package

40

Contains DI Package

05030267128020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-