Catalog Number

-

Brand Name

Transport Kit with Pediatric Elongated Non-Rebrreather Mask with Safety Vent

Version/Model Number

9443

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

OGL

Product Code Name

Oxygen Administration Kit

Public Device Record Key

cacb7449-69ad-49bd-8327-2721d2810b2b

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

February 05, 2018

Package DI Number

10709078004824

Quantity per Package

25

Contains DI Package

00709078004827

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-