Catalog Number

RES2210

Brand Name

Pediatric Aerosol Mask

Version/Model Number

RES2210

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"

-

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

264efb48-b33f-4d63-9c0b-c4412e59fa2a

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

10848530061026

Quantity per Package

50

Contains DI Package

00848530061029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-