FDA.reportPublic FDA data

Meridian™ Iontophoretic Drug Delivery Electrode

Primary DI
00702173152929
Brand
Meridian™ Iontophoretic Drug Delivery Electrode
Company
WR MEDICAL ELECTRONICS CO INC
Model
5292
Published
2017-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGJDevice, Iontophoresis, Other Uses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGJDevice, Iontophoresis, Other UsesPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000574000IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)Wr Medical Electronics Co.2000-08-09EGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00702173152929PrimaryGS10
00702173052922Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00702173152929007021731529297021731529290702173152929
00702173052922007021730529227021730529220702173052922

GMDN Terms#

Term, Definition table
TermDefinition
Drug-delivery iontophoresis system electrode, activeA dedicated, active, electrical conductor that is a component of an iontophoresis system for transcutaneous drug delivery of a localized medication (e.g., corticosteroids or local anaesthetics). It is typically a layered pad that is attached to the skin surface of the patient at the target site, and connected to the current generator with a lead wire. An applied electric field causes the ionic-solution medication to transport from a reservoir within the pad for patient exposure. It comes in a variety of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-604-8400info@wrmed.com

Regulatory Flags#

DUNS number
006196604
Device count
20
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00702173456508HRV Acquire56502016-07-25
00702173131870Surgical Probe Monopolar31872016-08-29
00702173131887Surgical Probe, Monopolar w/Protected Plug31882016-08-29
00702173132174Silverstein Facial Nerve Stimulator Remote Probe32172016-08-29
00702173139005Hilger Dual Stim39002016-08-29
00702173139050Hilger Dual-Stimulator Remote Probe39052016-08-29
00702173139104Silverstein Facial Nerve StimulatorS82016-08-29
00702173122755TherabathTB92020-03-11
00702173122809TherabathTB102019-11-06
00702173151885Q-Sweat51882016-09-12
00702173151915Meridian™ Iontophoretic Drug Delivery Electrode51912016-09-12
00702173155920Iontophor®-II6111PM/DX2017-02-21
00702173355696CASEIV2016-08-29
00702173123202TherabathTB62016-08-29
00702173123226TherabathTB72016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10768627016497Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016995PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016988PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
20768627016494Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
10768627016299ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016305ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016312ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016282ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016296ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016302ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016319ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
04250571300832PhotheraHIDREX GmbHEGJ2025-01-07
08054383090006MATTIOLIMATTIOLI ENGINEERING ITALIA SPAEGJ2024-09-26
00850030915047Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915078Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915108Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915252RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915269RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915276RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915283RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915290RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915306RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915313RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915320RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915337RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915344RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915351RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915368RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915016Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915054Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02