Catalog Number

3472INF-00

Brand Name

Respironics

Version/Model Number

3472INF-00

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

BZA

Product Code Name

CONNECTOR, AIRWAY (EXTENSION)

Public Device Record Key

a4a8cc97-f90f-483c-b9e0-f0ba70eecdae

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

September 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-