Catalog Number

PRT-00801-001

Brand Name

VOCSN Patient Breathing Package

Version/Model Number

Pediatric, Passive, 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

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

5aa5d2b1-380e-4977-be52-d91931c3469b

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

July 11, 2018

Package DI Number

00855573007662

Quantity per Package

10

Contains DI Package

00855573007655

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-