Catalog Number

10A0994

Brand Name

Hospital Wearable Defibrillator

Version/Model Number

HWD 1000 Electrode Cable

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P010030

Product Code

MVK

Product Code Name

Wearable Automated External Defibrillator

Public Device Record Key

d7f6f370-3096-4a5d-878d-99dfa7126177

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-