Catalog Number

384-00

Brand Name

HUDSON RCI

Version/Model Number

IPN044283

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

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

-

Product Code

BZA

Product Code Name

CONNECTOR, AIRWAY (EXTENSION)

Public Device Record Key

2b719235-61b7-4ab6-802f-9c48805063e5

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

September 15, 2018

Package DI Number

24026704396195

Quantity per Package

30

Contains DI Package

04026704396191

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case