Catalog Number

-

Brand Name

Resusa-Tee T-Piece Resuscitator

Version/Model Number

10-51506

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K142096,K142096

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

a61e42b6-7928-4b7e-9ea4-61d3b5bb1201

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

30641043515062

Quantity per Package

10

Contains DI Package

10641043515068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-