Catalog Number

-

Brand Name

RÜSCH

Version/Model Number

120900020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 16, 2019

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

K874742

Product Code

BTO

Product Code Name

Tube, Tracheostomy (W/Wo Connector)

Public Device Record Key

8268ec95-df99-404c-8cc6-a124e007a51d

Public Version Date

July 17, 2019

Public Version Number

4

DI Record Publish Date

January 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-