Catalog Number

5-16139

Brand Name

HUDSON RCI

Version/Model Number

IPN044862

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

K851856,K851856,K851856

Product Code

CBI

Product Code Name

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

Public Device Record Key

7e0684e2-a975-40ad-8f38-f59af00363bd

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

24026704397673

Quantity per Package

1

Contains DI Package

04026704397679

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box