Catalog Number

1751

Brand Name

Hudson RCI

Version/Model Number

IPN042770

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"

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

K900783,K900783

Product Code

CAF

Product Code Name

NEBULIZER (DIRECT PATIENT INTERFACE)

Public Device Record Key

3615ea80-bcb5-45f5-ac8a-b1da7ce089e5

Public Version Date

January 09, 2020

Public Version Number

8

DI Record Publish Date

September 16, 2016

Package DI Number

24026704595543

Quantity per Package

50

Contains DI Package

04026704595549

Package Discontinue Date

July 23, 2018

Package Status

Not in Commercial Distribution

Package Type

Case