Catalog Number

-

Brand Name

Hybernite

Version/Model Number

Sleepbox Heated Tube

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 13, 2017

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

cc0e23be-bef3-49c4-b4a9-78aecd14bc98

Public Version Date

December 11, 2019

Public Version Number

3

DI Record Publish Date

July 13, 2017

Package DI Number

15404013000989

Quantity per Package

54

Contains DI Package

05404013000982

Package Discontinue Date

July 13, 2017

Package Status

Not in Commercial Distribution

Package Type

-