Catalog Number

-

Brand Name

CO2/ O2 Pediatric Elongated Mask

Version/Model Number

0562P

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

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

b837c745-b8e7-462e-abf7-e7bdc5822319

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

May 15, 2018

Package DI Number

10709078005722

Quantity per Package

50

Contains DI Package

00709078005725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-