AccessGUDID - DEVICE: PadPro (10653405042495)

GUDID

Device Identifier (DI) Information

Brand Name: PadPro
Version or Model: 2001Z-PC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2001Z-PC
Company Name: Conmed Corporation

Primary DI Number: 10653405042495
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: PADPRO Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, Adult/Child greater than 10 kg Radiotransparent Electrode, ZOLL 60" (152 cm)

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":	No
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 [?]
K014209	000
P200004	000

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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3d34dd9f-8915-4f89-b12a-9f5932ce643d
Public Version Date: April 04, 2025
Public Version Number: 9
DI Record Publish Date: September 23, 2014