Catalog Number

FS80023

Brand Name

DioBreeze Cart

Version/Model Number

FS80023

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

K183307

Product Code

BZN

Product Code Name

Cart, Emergency, Cardiopulmonary (Excluding Equipment)

Public Device Record Key

f778c948-28d0-481e-b22b-bafcd765f672

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-