Catalog Number

-

Brand Name

ACIST HDi® Patient Interface Module (PIM)

Version/Model Number

017989

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 2017

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

OBJ

Product Code Name

Catheter, Ultrasound, Intravascular

Public Device Record Key

7c7793a8-5bb0-4ea8-a22a-4c3713013e2e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Package DI Number

30841716101152

Quantity per Package

1

Contains DI Package

10841716101158

Package Discontinue Date

August 17, 2017

Package Status

Not in Commercial Distribution

Package Type

Shelf Box