Catalog Number

386-78

Brand Name

HUDSON RCI

Version/Model Number

IPN044300

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

K760866,K760866,K760866

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Public Device Record Key

fff23bc1-6e78-4760-8ce3-acc08f5f6e77

Public Version Date

February 21, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

24026704589917

Quantity per Package

1

Contains DI Package

04026704589913

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case