Catalog Number

-

Brand Name

Dreamprep

Version/Model Number

100433

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)

-

Over the Counter (OTC)

Yes

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

0cf94f70-818f-44df-ad78-868ad69f43d5

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Package DI Number

10850003157020

Quantity per Package

8

Contains DI Package

00850003157023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-