Catalog Number

80004-003

Brand Name

ASSURE, Therapy Cable

Version/Model Number

80004-003

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

-

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

c5ad5e22-c50d-499b-a7bd-9ceb8d23eab8

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

-