FDA.report

Ionto Plus Small Electrode

Primary DI
80092237901751
Brand
Ionto Plus Small Electrode
Company
Compass Richmar, LLC
Model
201-455
Device description
Iontophoresis Drug Delivery Small Kit Electrodes - 1.5cc, 3mA-minute, incl. buffered return 2.75" x 2.75"
Published
2018-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EGJDevice, Iontophoresis, Other Uses

Product Code Classifications

CodeDeviceSpecialtyClass
EGJDevice, Iontophoresis, Other UsesPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30092237901756PackageGS112In Commercial Distribution
80092237901751PackageGS124In Commercial Distribution
00092237901755PrimaryGS10
01092237901754Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3009223790175630092237901756
8009223790175180092237901751
00092237901755000922379017550922379017550092237901755
01092237901754010922379017541092237901754

GMDN Terms

TermDefinition
Drug-delivery iontophoresis patchA non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive, intended to be used as an alternative to injections for the transport of ionic-solution medication (e.g., soluble salts) through the movement of ions, resulting from an applied electric field, to locally administer the medication transcutaneously (transdermal). It typically consists of a positive and a negative electrode, a reservoir/drug chamber(s) that hold the medication, a battery, and a perimeter adhesive; the reservoir must be filled by the user with the drug prior to use. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
080930531
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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10853904006060BodyMed Iontophoresis Electrode KitLarge, Box of 122016-05-02
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10850689007336STICK-E-PADS203-6742016-11-18
10850689007343STICK-E-PADS203-6752016-11-18
10850689007350STICK-E-PADS203-6732016-11-18
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10850689007374STICK-E-PADS203-6802016-11-18
10850689007381STICK-E-PADS203-6812016-11-18
10850689007398STICK-E-PADS203-6762016-11-18
10850689007404STICK-E-PADS203-6772016-11-18
10850689007428ValueStim202-6752016-11-18
10850689007442ValueStim202-6762016-11-18
10850689007466Adhesive Electrodes202-4542016-11-18
10850689007473Adhesive Electrodes202-4552016-11-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00768627016988PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
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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
00850030915016Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02
00850030915054Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02
00850030915085Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02
00850030915115Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02
10850030915259RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915266RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915273RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915280RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915297RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915303RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915310RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915327RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915334RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915341RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915358RichmarSouth Dakota Partners Inc.EGJ2023-08-02
10850030915365RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00877067000010DERMADRYDermadry Laboratories IncEGJ2020-03-17
00877067000027DERMADRYDermadry Laboratories IncEGJ2020-03-17
00877067000034DERMADRYDermadry Laboratories IncEGJ2020-03-17
04260587510200The FischerSaalmann medical GmbH & Co. KGEGJ2020-03-15
04250571300818DAAVLINHIDREX GmbHEGJ2020-02-06
00815991022050BodyMed BOXOUT, LLCEGJ2018-12-27