Dupel BLUE
- Primary DI
- 00850030915085
- Brand
- Dupel BLUE
- Company
- South Dakota Partners Inc.
- Model
- 199335-001
- Device description
- Iontophoresis Electrode, Medium Standard 2.5 mL
- Published
- 2023-08-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| EGJ | Device, Iontophoresis, Other Uses |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | Physical Medicine | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850030915085 | Package | GS1 | 2 | In Commercial Distribution |
| 00850030915092 | Package | GS1 | 12 | In Commercial Distribution |
| 00850030915078 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850030915085 | 00850030915085 | 850030915085 | 0850030915085 |
| 00850030915092 | 00850030915092 | 850030915092 | 0850030915092 |
| 00850030915078 | 00850030915078 | 850030915078 | 0850030915078 |
GMDN Terms
| Term | Definition |
|---|---|
| Drug-delivery iontophoresis system electrode, active | A 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. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 080639793
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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 | Catalog | Published |
|---|---|---|---|---|
| 00850030915016 | Dupel BLUE | 199332-001 | 2023-08-02 | |
| 10850030915020 | Mio-Guard | MGF10001 | 2023-08-02 | |
| 10850030915037 | Mio-Guard | MGF10002 | 2023-08-02 | |
| 00850030915054 | Dupel BLUE | 199334-001 | 2023-08-02 | |
| 00850030915115 | Dupel BLUE | 199336-001 | 2023-08-02 | |
| 10850030915150 | Mio-Guard | MGF10003 | 2023-08-02 | |
| 10850030915167 | Mio-Guard | MGF10005 | 2023-08-02 | |
| 10850030915174 | Mio-Guard | MGF10006 | 2023-08-02 | |
| 10850030915181 | Mio-Guard | MGF10004 | 2023-08-02 | |
| 00850030915191 | Richmar | RM-A1220 | 2023-08-02 | |
| 00850030915207 | Richmar | RM-400-046 | 2023-08-02 | |
| 00850030915214 | Richmar | RM-410-010 | 2023-08-02 | |
| 00850030915221 | Richmar | RM-410-012 | 2023-08-02 | |
| 00850030915238 | Richmar | RM-410-014 | 2023-08-02 | |
| 00850030915245 | Richmar | RM-410-016 | 2023-08-02 | |
| 10850030915259 | Richmar | RM-201-455 | 2023-08-02 | |
| 10850030915266 | Richmar | RM-201-449 | 2023-08-02 | |
| 10850030915273 | Richmar | RM-201-453 | 2023-08-02 | |
| 10850030915280 | Richmar | RM-201-452 | 2023-08-02 | |
| 10850030915297 | Richmar | RM-201-4552 | 2023-08-02 |
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|---|---|---|---|---|
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| 20768627016494 | Push Patch Controlled Released 12.0 | NORTH COAST MEDICAL, INC. | EGJ | 2025-12-01 |
| 10768627016282 | ActivaTek Ionto4 Kit | NORTH COAST MEDICAL, INC. | EGJ | 2025-04-02 |
| 20768627016296 | ActivaTek Ionto4 Kit | NORTH COAST MEDICAL, INC. | EGJ | 2025-04-02 |
| 20768627016302 | ActivaTek Ionto4 Kit | NORTH COAST MEDICAL, INC. | EGJ | 2025-04-02 |
| 20768627016319 | ActivaTek Ionto4 Butterfly | NORTH COAST MEDICAL, INC. | EGJ | 2025-04-02 |
| 04250571300832 | Phothera | HIDREX GmbH | EGJ | 2025-01-07 |
| 08054383090006 | MATTIOLI | MATTIOLI ENGINEERING ITALIA SPA | EGJ | 2024-09-26 |
| 00850030915016 | Dupel BLUE | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 00850030915054 | Dupel BLUE | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 00850030915115 | Dupel BLUE | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915259 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915266 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915273 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915280 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915297 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915303 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915310 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915327 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915334 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915341 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915358 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 10850030915365 | Richmar | South Dakota Partners Inc. | EGJ | 2023-08-02 |
| 00877067000010 | DERMADRY | Dermadry Laboratories Inc | EGJ | 2020-03-17 |
| 00877067000027 | DERMADRY | Dermadry Laboratories Inc | EGJ | 2020-03-17 |
| 00877067000034 | DERMADRY | Dermadry Laboratories Inc | EGJ | 2020-03-17 |
| 04260587510200 | The Fischer | Saalmann medical GmbH & Co. KG | EGJ | 2020-03-15 |
| 04250571300818 | DAAVLIN | HIDREX GmbH | EGJ | 2020-02-06 |
| 00815991022050 | BodyMed | BOXOUT, LLC | EGJ | 2018-12-27 |
| 00815991022067 | BodyMed | BOXOUT, LLC | EGJ | 2018-12-27 |