Catalog Number

-

Brand Name

Hybernite RT

Version/Model Number

Hybernite RT 12 ins+Inc

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)

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

f2d7287b-d20d-46da-a3e0-0b4345197cd3

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

July 19, 2017

Package DI Number

15404013000231

Quantity per Package

60

Contains DI Package

05404013000234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-