Catalog Number

CNSYS1HT15

Brand Name

System One Humidifier

Version/Model Number

System One Heated Tube Humidifier, CN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2021

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

-

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

K113068

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

2064cda4-03b7-4af7-8a90-ed60de676309

Public Version Date

March 05, 2021

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-