Catalog Number

-

Brand Name

Heated CPAP Tube

Version/Model Number

TUB06HPR

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

-

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

K201418,K201418

Product Code

BZE

Product Code Name

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

Public Device Record Key

6f542281-2ad9-48f1-9eed-28493f455039

Public Version Date

October 22, 2021

Public Version Number

1

DI Record Publish Date

October 14, 2021

Package DI Number

10848530090606

Quantity per Package

50

Contains DI Package

00848530090609

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-