Catalog Number

-

Brand Name

Neo-Vent™,Humidified Infant T-Piece Resuscitation Kit

Version/Model Number

0422

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

-

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

3803b6e8-f92d-493f-a669-44eb433dc839

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 02, 2017

Package DI Number

10709078002448

Quantity per Package

10

Contains DI Package

00709078002441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-