Catalog Number

-

Brand Name

ACIST RXi® Ao Interface Box

Version/Model Number

018311

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

38874246-fafb-4295-a6ae-353f837b5409

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 08, 2016

Package DI Number

30841716101442

Quantity per Package

1

Contains DI Package

10841716101448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box