Catalog Number

RES027OP

Brand Name

Sunset T HME with built-in Oxygen Port

Version/Model Number

RES027OP

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Public Device Record Key

0ff12cd6-2e6a-4477-b476-7c274bc39666

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 20, 2018

Package DI Number

20848530083438

Quantity per Package

27

Contains DI Package

10848530083431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-