Catalog Number

11130-000037

Brand Name

STANDARD HARD PADDLES

Version/Model Number

11130

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

-

Product Code

LDD

Product Code Name

Dc-defibrillator, low-energy, (including paddles)

Public Device Record Key

57e0a033-2230-4c4c-8e5a-a1dd2bd22417

Public Version Date

May 18, 2020

Public Version Number

2

DI Record Publish Date

April 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-