Catalog Number

1659

Brand Name

HUDSON RCI

Version/Model Number

IPN042692

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)

-

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

832e7bf9-f6bd-4bbc-b5bc-d20cb8e259a1

Public Version Date

October 21, 2020

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

24026704595093

Quantity per Package

50

Contains DI Package

04026704595099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box