Catalog Number

PRT-00798-00X

Brand Name

VOCSN Patient Breathing Package

Version/Model Number

Adult, Active, Heated, Oxygen, Blue

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162877,K162877

Product Code

BZE

Product Code Name

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

Public Device Record Key

746b3a81-c230-40fb-a6df-b1496bc4230a

Public Version Date

May 13, 2021

Public Version Number

2

DI Record Publish Date

October 07, 2020

Package DI Number

00850018761079

Quantity per Package

10

Contains DI Package

00850018761062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-