Dupel Kit Iontophoresis Device

GUDID 00888912151399

EMPI, INC.

Drug-delivery iontophoresis system, reusable

• Primary Device ID: 00888912151399
• NIH Device Record Key: d0bfcd62-5e15-4b92-a127-6e43369026f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dupel Kit Iontophoresis Device
• Version Model Number: 199518-001
• Company DUNS: 039375910
• Company Name: EMPI, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888912151399 [Primary]

FDA Product Code

• EGJ: Device, Iontophoresis, Other Uses

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-25

Devices Manufactured by EMPI, INC.

• 00888912151276 - Ass'y, Kit, Hybresis Charging Station: 2020-02-06
• 00888912024075 - Trans QE Medium 2.5-3.0 cc electrode, Box of 12: 2018-03-29
• 00888912024082 - Iogel Small 1.5 cc electrode, Box of 12: 2018-03-29
• 00888912151252 - Kit, Hybresis Controller: 2018-03-29
• 00888912151269 - Hybresis Iontophoresis Patch, Medium/Standard, Box of 6: 2018-03-29
• 00888912151283 - Action Patch Electrode ~ box of 4: 2018-03-29
• 00888912151290 - Iontophoresis Electrode Small 2.0 mL 3.75"x2.25" Box of 12: 2018-03-29
• 00888912151306 - Iontophoresis Electrode Medium 2.0 mL 3"x3" Box of 12: 2018-03-29