FDA.reportPublic FDA data

Push Patch Controlled Released 12.0

Primary DI
20768627016494
Brand
Push Patch Controlled Released 12.0
Company
NORTH COAST MEDICAL, INC.
Model
4549
Catalog number
NC88191
Device description
Push Patch Controlled Released 12.0 - Private labeled ActivaPatch IontoGo 12.0 iontophoresis wireless electrode
Published
2025-12-01
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

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
20768627016494PackageGS140In Commercial Distribution
10768627016497PrimaryGS10
00768627016490Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076862701649420768627016494
1076862701649710768627016497
00768627016490007686270164907686270164900768627016490

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
060121928
Device count
6
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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768627017145Blue Diamond 360 Needle Stimulator4581NCBD-3602026-06-01
00768627017152Blue Diamond 360 Needle Stimulator Lead Wires - Alligator Clip4581NCBD-360-012026-06-01
00768627017169Blue Diamond 360 Needle Stimulator Lead Wires - Pigtail4581NCBD-360-022026-06-01
00768627017275Norco Sharps Container4595NC229412026-06-01
00768627017282Norco Nitrile Gloves4594NC20545-12026-06-01
00768627017299Norco Nitrile Gloves4594NC20545-122026-06-01
00768627017305Norco Nitrile Gloves4594NC20545-32026-06-01
00768627017312Norco Nitrile Gloves4594NC20545-42026-06-01
10768627016497Push Patch Controlled Released 12.04549NC881912025-12-01
00768627016995PushPatch Delicate (6)4549NC881922025-12-01
00768627016988PushPatch Delicate (6)4549NC881922025-12-01
10768627016299ActivaTek Ionto4 KitNC8937645112025-04-02
10768627016305ActivaTek Ionto4 KitNC8937745112025-04-02
10768627016312ActivaTek Ionto4 ButterflyNC8937845112025-04-02
10768627016282ActivaTek Ionto4 KitNC8937545112025-04-02
20768627016296ActivaTek Ionto4 KitNC8937645112025-04-02
20768627016302ActivaTek Ionto4 KitNC8937745112025-04-02
20768627016319ActivaTek Ionto4 ButterflyNC8937845112025-04-02
00768627001632NorcoNC8948141232025-03-26
00768627160285Blue DiamondNCBD-161343082023-09-01

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
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
00850030915085Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02