Catalog Number

MA-J00097

Brand Name

IMACTIS®

Version/Model Number

J00097

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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)

-

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

dce00d62-728a-4172-a2a9-2dcea6df2dde

Public Version Date

January 08, 2019

Public Version Number

1

DI Record Publish Date

December 08, 2018

Package DI Number

B681J000971

Quantity per Package

1

Contains DI Package

B681J000970

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard