Catalog Number

386-83

Brand Name

HUDSON RCI

Version/Model Number

IPN044304

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"

-

For Single-Use

-

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

K923946,K923946,K923946

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Public Device Record Key

0d491289-06a6-46bf-803c-4fd7b6181497

Public Version Date

February 21, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

24026704396379

Quantity per Package

1

Contains DI Package

04026704396375

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case