FDA.reportPublic FDA data

PushPatch Delicate (6)

Primary DI
00768627016995
Brand
PushPatch Delicate (6)
Company
NORTH COAST MEDICAL, INC.
Model
4549
Catalog number
NC88192
Device description
Drug-delivery iontophoresis patch
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768627016995PrimaryGS10
00768627016988Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768627016995007686270169957686270169950768627016995
00768627016988007686270169887686270169880768627016988

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.

Contacts#

Phone, Email table
PhoneEmail
4087765000custserv@ncmedical.com

Regulatory Flags#

DUNS number
060121928
Device count
6
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10768627016497Push Patch Controlled Released 12.04549NC881912025-12-01
00768627016988PushPatch Delicate (6)4549NC881922025-12-01
20768627016494Push Patch Controlled Released 12.04549NC881912025-12-01
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
00768627160292Blue DiamondNCBD-181343082023-09-01
00768627160308Blue DiamondNCBD-201343082023-09-01
00768627160315Blue DiamondNCBD-251343082023-09-01
00768627160322Blue DiamondNCBD-221343082023-09-01
00768627160339Blue DiamondNCBD-253043082023-09-01
00768627160346Blue DiamondNCBD-303043082023-09-01
00768627160353Blue DiamondNCBD-254043082023-09-01
00768627160360Blue DiamondNCBD-304043082023-09-01

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