Catalog Number

5-16035

Brand Name

HUDSON RCI

Version/Model Number

IPN044855

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

K961977,K961977,K961977

Product Code

CBI

Product Code Name

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

Public Device Record Key

bc1d86d4-267c-47ba-b04f-3f1f9afd2cbd

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

24026704397604

Quantity per Package

1

Contains DI Package

04026704397600

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box