FDA.reportPublic FDA data

Richmar

Primary DI
00850030915313
Brand
Richmar
Company
South Dakota Partners Inc.
Model
RM-201-4532
Device description
Richmar Large Ionto4 Electrode, Bag of 12
Published
2023-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10850030915310PackageGS12Not in Commercial Distribution
20850030915317PackageGS112Not in Commercial Distribution
00850030915313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003091531010850030915310
2085003091531720850030915317
00850030915313008500309153138500309153130850030915313

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.

Regulatory Flags#

DUNS number
080639793
Device count
1
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
00850030915207RichmarRM-400-0462023-08-02
00850030915641SDPSD-HP-1711-CX 2023-08-02
00850030915658SDPSD-HP-1711-LG 2023-08-02
00850030915665SDPSD-HP-1713-OS 2023-08-02
00850030915672SDPSD-HP-1905-UN 2023-08-02
00850030915689SDPSD-HP-1210-ST2023-08-02
00850030915214RichmarRM-410-0102023-08-02
00850030915221RichmarRM-410-0122023-08-02
00850030915238RichmarRM-410-0142023-08-02
00850030915245RichmarRM-410-0162023-08-02
00850030915023Mio-GuardMGF100012023-08-02
00850030915030Mio-GuardMGF100022023-08-02
00850030915153Mio-GuardMGF100032023-08-02
00850030915160Mio-GuardMGF100052023-08-02
00850030915177Mio-GuardMGF100062023-08-02
00850030915184Mio-GuardMGF100042023-08-02
00850030915252RichmarRM-201-4552023-08-02
00850030915269RichmarRM-201-4492023-08-02
00850030915276RichmarRM-201-4532023-08-02
00850030915283RichmarRM-201-4522023-08-02

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
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