Catalog Number

780-51

Brand Name

HUDSON RCI

Version/Model Number

IPN045230

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

K031383,K031383

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Public Device Record Key

cce1afcd-3ca9-4097-bf8f-a35946bac4fa

Public Version Date

October 24, 2022

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

24026704598292

Quantity per Package

10

Contains DI Package

04026704598298

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case