Catalog Number

-

Brand Name

Hybernite

Version/Model Number

Comfortline 3B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 03, 2028

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

-

Product Code

BZE

Product Code Name

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Public Device Record Key

7434bee3-dc99-46be-84dc-2d6abc129473

Public Version Date

July 04, 2022

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

15404013000101

Quantity per Package

10

Contains DI Package

05404013000104

Package Discontinue Date

July 03, 2028

Package Status

In Commercial Distribution

Package Type

-