Catalog Number

0351-600-000

Brand Name

NA

Version/Model Number

0351600000

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

-

Product Code

BZN

Product Code Name

CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Public Device Record Key

1b1a7e3c-9a82-4249-ab03-8be3326c0dc3

Public Version Date

November 27, 2019

Public Version Number

1

DI Record Publish Date

November 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-