Catalog Number

860-DTP

Brand Name

HUDSON RCI

Version/Model Number

IPN049340

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

K131912,K131912

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Public Device Record Key

4006fce0-fc2a-40e8-93f9-cffc6436fdd1

Public Version Date

October 03, 2018

Public Version Number

2

DI Record Publish Date

July 30, 2018

Package DI Number

24026704629071

Quantity per Package

10

Contains DI Package

14026704629074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box