Catalog Number

-

Brand Name

Disposable breathing circuit, 1.70m

Version/Model Number

28110

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"

-

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

K193191,K193191,K193191,K193191

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

e88ee308-e036-4985-aacf-ef7da81952de

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

December 07, 2020

Package DI Number

04054685075750

Quantity per Package

10

Contains DI Package

04054685129996

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-