Catalog Number

-

Brand Name

ACIST RXi® Console, Refurbished

Version/Model Number

018084

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

K132474

Product Code

OBI

Product Code Name

Catheter, Pressure Monitoring, Cardiac

Public Device Record Key

4c3c0c91-3192-457b-bdc6-fbbbd9225b95

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-