Catalog Number

780-35

Brand Name

HUDSON RCI

Version/Model Number

IPN913823

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

K031383,K031383,K031383

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Public Device Record Key

2c0b6090-7fc2-4a47-94c2-72d56c477cbf

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

August 20, 2020

Package DI Number

24026704660265

Quantity per Package

10

Contains DI Package

14026704660268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box