Catalog Number

501003-000065

Brand Name

RUSCH

Version/Model Number

IPN044613

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

-

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

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

f05585c6-0c6f-4976-8893-205a22911647

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

44026704063275

Quantity per Package

344

Contains DI Package

24026704063271

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton