Catalog Number

-

Brand Name

Dreamway connector kit

Version/Model Number

100565

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

-

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

K172335,K172335

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

8bff7da3-1b9c-487b-8aae-f7f50541f8bf

Public Version Date

August 24, 2022

Public Version Number

2

DI Record Publish Date

May 10, 2021

Package DI Number

10850003157051

Quantity per Package

24

Contains DI Package

00850003157054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-