Catalog Number

-

Brand Name

Neo-Tee T-Piece Resuscitator

Version/Model Number

10-50841

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

K093913,K093913

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

f7299f7f-0a64-43c5-ad4f-abc1e765b33e

Public Version Date

May 08, 2020

Public Version Number

2

DI Record Publish Date

August 30, 2018

Package DI Number

30641043508415

Quantity per Package

10

Contains DI Package

10641043508411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-