Catalog Number

124700002

Brand Name

RUSCH

Version/Model Number

IPN042303

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

CAE

Product Code Name

AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Public Device Record Key

11372e68-d7dd-4fb9-bfc4-d5d7d6866b86

Public Version Date

December 12, 2019

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

24026704547023

Quantity per Package

12

Contains DI Package

04026704547029

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box