Catalog Number

900003

Brand Name

AcQMap

Version/Model Number

900003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

MTD

Product Code Name

Catheter,Intracardiac Mapping,High-Density Array

Public Device Record Key

3fb126df-b75f-406e-87d4-86a0a6e5a54f

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

February 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-