Catalog Number

230100000

Brand Name

RUSCH

Version/Model Number

IPN044051

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

K951046,K951046

Product Code

BSK

Product Code Name

Cuff, tracheal tube, inflatable

Public Device Record Key

f8505114-4037-43c9-8b03-e697eb4fe0d3

Public Version Date

December 11, 2019

Public Version Number

5

DI Record Publish Date

October 16, 2015

Package DI Number

44026704554100

Quantity per Package

5

Contains DI Package

04026704554102

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case