Catalog Number

-

Brand Name

ACIST RXi® System

Version/Model Number

014666

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,K132474

Product Code

OBI

Product Code Name

Catheter, Pressure Monitoring, Cardiac

Public Device Record Key

9136283c-eadb-45c6-b7a2-88a0132e17cc

Public Version Date

September 03, 2018

Public Version Number

1

DI Record Publish Date

August 02, 2018

Package DI Number

30841716101732

Quantity per Package

1

Contains DI Package

10841716101738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box