Catalog Number

3326633-004

Brand Name

ASSURE, Charger

Version/Model Number

3326633-004

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

P200037,P200037,P200037,P200037

Product Code

MVK

Product Code Name

Wearable Automated External Defibrillator

Public Device Record Key

3f92465c-4c29-45c4-85f3-3b179db8a2be

Public Version Date

January 12, 2022

Public Version Number

2

DI Record Publish Date

November 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-