Catalog Number

-

Brand Name

Neo-Vent™

Version/Model Number

0419

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"

Yes

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

K923618,K923618

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

eb8f7b21-acaf-492d-8815-bee4ec93a4c8

Public Version Date

July 30, 2021

Public Version Number

3

DI Record Publish Date

October 27, 2017

Package DI Number

10709078004664

Quantity per Package

10

Contains DI Package

00709078004667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-