Catalog Number

330600-000060

Brand Name

RUSCH

Version/Model Number

IPN044217

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)

Yes

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

K010596,K010596,K010596

Product Code

CBI

Product Code Name

TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Public Device Record Key

2e9530d4-bfc7-4019-9a76-01653e6557f8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 16, 2015

Package DI Number

44026704042461

Quantity per Package

56

Contains DI Package

24026704042467

Package Discontinue Date

March 02, 2018

Package Status

Not in Commercial Distribution

Package Type

Carton