FDA.reportPublic FDA data

ActivaDose II

Primary DI
00859975005011
Brand
ActivaDose II
Company
ACTIVATEK INC.
Model
001-48
Device description
Iontophoresis Delivery Unit
Published
2014-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EGJDevice, Iontophoresis, Other Uses

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859975005018PackageGS110In Commercial Distribution
00859975005011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085997500501810859975005018
00859975005011008599750050118599750050110859975005011

GMDN Terms#

Term, Definition table
TermDefinition
Drug-delivery iontophoresis system generatorA battery-powered, portable device 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 supplies a constant direct current (e.g., 0.5 to 4 milliampere (mA) through a delivery electrode attached to the skin surface, and to which is typically attached a small reservoir containing a buffering agent and the medication (e.g., a corticosteroid or anaesthetic). A buffering agent return electrode completes the circuit. The reusable device typically includes setting controls and a display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790584176
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768627892506NorcoNC89250B2014-09-23
00768627892513NorcoNC89251B2014-09-23
00768627892520NorcoNC89252B2014-09-23
00768627892551NorcoNC89255B2014-09-23
00859975005202ActivaPatch IontoGo 4.0001-50NC891892016-06-14
00859975005226ActivaPatch IontoGo 12.0001-90NC891912016-06-14
00859975005042Trivarion001-152014-11-26
00859975005059Trivarion001-202014-11-26
00859975005066Trivarion001-352014-11-26
00859975005073Trivarion001-602014-11-26
00859975005080Trivarion Medium & Butterfly SampleTRVN-SASA891792016-07-01
00859975005097ActivaPatch IontoGo 4.0 Sample00150-SAMPLESA891892016-07-01
00859975005103ActivaPatch IontoGo 12.0 Sample00190-SAMPLESA891912016-07-01
00859975005127Trivarion Large Sample00135-SAMPLESA89182B2016-07-01
00859975005141Trivarion Small Sample00115-SAMPLESA89180B2016-07-01
00859975005158ActivaPatch IntelliDose 2.5 Sample00140-SAMPLESA891882016-08-22
10859975005209ActivaPatch IontoGo 4.0001-50NC891892016-06-14
00859975005219ActivaPatch 001-40NC891882016-08-22
10859975005223ActivaPatch IontoGo 12.0001-90NC891912016-06-14
20768627892500NorcoNC89250B2014-09-23

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