Catalog Number

-

Brand Name

Neo-Tee T-Piece Resuscitator

Version/Model Number

10-50834

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 12, 2021

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

a747a3fc-7e53-4011-8e34-84e275e9315c

Public Version Date

July 13, 2021

Public Version Number

6

DI Record Publish Date

October 31, 2016

Package DI Number

30641043508347

Quantity per Package

10

Contains DI Package

10641043508343

Package Discontinue Date

July 12, 2021

Package Status

Not in Commercial Distribution

Package Type

-