Catalog Number

PH304

Brand Name

Cardio Clear

Version/Model Number

PH304

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

K103651,K103651

Product Code

LDD

Product Code Name

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

Public Device Record Key

086f36f3-ee58-4938-afb2-32c1e62b69c9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 28, 2015

Package DI Number

10814907020125

Quantity per Package

10

Contains DI Package

00814907020128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box