Catalog Number

-

Brand Name

Neo-Vent Infant T-Piece Resuscitation Circuit, Gas Supply

Version/Model Number

0416

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

c735bd4a-b74e-4ffc-bc48-97d6c1fa888c

Public Version Date

July 30, 2021

Public Version Number

3

DI Record Publish Date

December 15, 2016

Package DI Number

10709078000376

Quantity per Package

10

Contains DI Package

00709078000379

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-