PDI® Electrode Prep Pad

Basic Information

• Brand Name: PDI® Electrode Prep Pad
• Primary DI: 00310819000475
• Version / Model: B59800
• Catalog Number: B59800
• Company Name: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
• Labeler DUNS: 800777117
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-03
• Public Version: 3
• Public Version Date: 2022-05-04
• Public Version Status: Update
• Public Device Record Key: 92d58e34-9441-429a-831b-26ed858b63d4
• Distribution End Date: 2022-05-04

Device Description

Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOY	Degreaser, Skin, Surgical	General, Plastic Surgery	878.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46466	Skin degreaser	A solvent material (e.g., liquid trichloroethane or trifluoroethane) used on the skin to dissolve surface skin oil, typically in preparation for surgery. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10310819000472	GS1	box	100	Not in Commercial Distribution	2022-05-04
Primary	00310819000475	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	1.2	Inch
Length	2.6	Inch