Catalog Number

800365-002

Brand Name

AcQMap

Version/Model Number

800365-002

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

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

7bbd1986-ebbe-4cd7-86df-aee1e7d11288

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

February 15, 2018

Package DI Number

10857042007033

Quantity per Package

5

Contains DI Package

00857042007036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-