Catalog Number

H104

Brand Name

Cardio Clear

Version/Model Number

H104

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103159,K103159

Product Code

LDD

Product Code Name

Dc-Defibrillator, Low-Energy, (Including Paddles)

Public Device Record Key

15de6094-48f6-4f0e-a294-967e7405c5f5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 28, 2015

Package DI Number

10814907020057

Quantity per Package

10

Contains DI Package

00814907020050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box