AccessGUDID - DEVICE: Powerheart® Polarized Adult Defibrillation Pads (00812394020249)

GUDID

Device Identifier (DI) Information

Brand Name: Powerheart® Polarized Adult Defibrillation Pads
Version or Model: 9660-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9660-001
Company Name: Cardiac Science Corporation

Primary DI Number: 00812394020249
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 190713797 *Terms of Use

Device Description: Polarized Defibrillation Pads(adult) with two-year shelf life

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45806	Multifunction cardiac electrode	An electrical conductor designed to be applied to an adult and/or paediatric patient for automatic or manual defibrillation, external pacing, cardioversion, and electrocardiographic monitoring through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses [e.g., electrocardiograph, electrocardiographic monitor(s), defibrillator]. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated External Defibrillators (Non-Wearable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73bc1a9d-e65c-42bd-9b9d-d7ee6ba3471e
Public Version Date: April 04, 2025
Public Version Number: 3
DI Record Publish Date: September 29, 2014