Waterpik PowerPulse

Basic Information

• Brand Name: Waterpik PowerPulse
• Primary DI: 00073950320528
• Version / Model: XAL-643ME
• Catalog Number: XAL-643ME
• Company Name: WATER PIK, INC.
• Labeler DUNS: 001804074
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-18
• Public Version: 1
• Public Version Date: 2022-07-26
• Public Version Status: New
• Public Device Record Key: dbe0b01f-2ec8-42cc-a130-8049ac1c0d88

Device Description

Hand held shower head, chrome

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
LYG	Massager, Therapeutic, Manual	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34661	External manual massager, home-use	A manual (non-powered) device specifically designed to apply external massage in the home. It is typically held in the hand of the user and drawn/rolled across the area of the body/muscles to be treated; it may also be designed to be placed on the floor for foot massage. The massaging components, e.g., roller heads or pads, may be interchangeable with others of different size and shape. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00073950320528	GS1

Customer Contacts

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