PadPro

Basic Information

• Brand Name: PadPro
• Primary DI: 10653405064244
• Version / Model: 2603R
• Catalog Number: 2603R
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 5
• Public Version Date: 2020-09-24
• Public Version Status: Update
• Public Device Record Key: 217f21f2-e259-4f18-925b-5f8a72a9ed43
• Distribution End Date: 2020-09-24

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
42404	Multifunction cardiac electrode, paediatric	A non-sterile electrical conductor designed to be applied to a 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20653405064241	GS1	CASE	10	Not in Commercial Distribution	2020-09-24
Primary	10653405064244	GS1

Premarket Submissions

Submission Number	Supplement Number
K020288	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 35 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 0 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius