Catalog Number

5-16135

Brand Name

HUDSON RCI

Version/Model Number

IPN049000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K180253,K180253,K180253,K180253

Product Code

CBI

Product Code Name

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

Public Device Record Key

cba53435-2d6a-48e2-a887-fda9f5ed6b96

Public Version Date

July 01, 2021

Public Version Number

7

DI Record Publish Date

September 20, 2018

Package DI Number

44026704617447

Quantity per Package

4

Contains DI Package

34026704617440

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case