Kit Dupel II International complete w/safety socket

Basic Information

• Brand Name: Kit Dupel II International complete w/safety socket
• Primary DI: 00888912151382
• Version / Model: 199438-001
• Company Name: EMPI, INC.
• Labeler DUNS: 039375910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-25
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ad593989-ee13-457d-9313-e52ea1ad723a

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	890.5525	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18155	Drug-delivery iontophoresis system, reusable	An assembly of portable devices that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It typically consists of a battery-powered current generator that supplies a constant direct current [e.g., 0.5 to 4 milliampere (mA)], a delivery electrode which typically contains a small reservoir of buffering agent and the medication (e.g., a corticosteroid or anaesthetic), a return electrode, and connecting lead wires. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888912151382	GS1