HARMONICA
- Primary DI
- 08054187381140
- Brand
- HARMONICA
- Company
- INVENTIS SRL
- Model
- HARMONICA
- Catalog number
- 11205
- Device description
- Harmonica is a wired digital video-otoscope that integrates a high-definition camera with chip-on-tip and a LED system.
- Published
- 2023-12-11
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| ERA | Otoscope |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ERA | Otoscope | Ear, Nose, Throat | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08054187381140 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08054187381140 | 08054187381140 | 8054187381140 |
GMDN Terms#
| Term | Definition |
|---|---|
| Otoscope, direct | An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 338454995
- Device count
- 1
- Premarket exempt
- true
- Serial number
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08054187381232 | easyTymp | easyTymp | 12467 | 2026-04-23 |
| 08054187381249 | easyTymp Docking Station | easyTymp Docking Station | 12468 | 2026-04-23 |
| 08054187380815 | Synapsys VHIT | Synapsys VHIT Basic | 10738 | 2025-01-08 |
| 08054187380822 | Synapsys VHIT | Synapsys VHIT Plus | 10739 | 2025-01-08 |
| 08054187380983 | VNG | VNG BASIC WIRELESS | 11463 | 2024-10-01 |
| 08054187380990 | VNG | VNG BASIC WIRELESS - XPR | 11463-XPR | 2024-10-01 |
| 08054187381003 | VNG | VNG PLUS WIRELESS | 11464 | 2024-10-01 |
| 08054187381010 | VNG | VNG PLUS WIRELESS - XPR | 11464-XPR | 2024-10-01 |
| 08054187381027 | VNG | VNG BASIC WIRED | 10619 | 2024-10-01 |
| 08054187381034 | VNG | VNG PLUS WIRED | 10620 | 2024-10-01 |
| 08054187381041 | VNG | VIDEO-SCOPE WIRELESS | 11447 | 2024-10-01 |
| 08054187381058 | VNG | VIDEO-SCOPE WIRELESS - XPR | 11447-XPR | 2024-10-01 |
| 08054187381065 | VNG | VIDEO-SCOPE WIRED | 11961 | 2024-10-01 |
| 08054187380730 | DRUM | DRUM | 11239 | 2017-08-24 |
| 08054187380020 | BELL | BELL PLUS | 10144 | 2016-09-17 |
| 08054187380044 | HARP | HARP BASIC | 10145 | 2016-09-17 |
| 08054187380051 | HARP | HARP BASIC WITH PRINTER | 10162 | 2016-09-17 |
| 08054187380068 | HARP | HARP PLUS | 10146 | 2016-09-17 |
| 08054187380075 | HARP | HARP PLUS WITH PRINTER | 10163 | 2016-09-17 |
| 08054187380082 | PIANO | PIANO BASIC | 10147 | 2016-09-17 |
Other Devices Sharing Product Codes#
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| 04260381960188 | Luxamed | Luxamed GmbH & Co. KG | ERA | 2026-08-26 |
| 04260381960195 | Luxamed | Luxamed GmbH & Co. KG | ERA | 2026-08-26 |
| 04260381960218 | Luxamed | Luxamed GmbH & Co. KG | ERA | 2026-08-26 |
| 04260381963493 | Luxamed | Luxamed GmbH & Co. KG | ERA | 2026-08-26 |
| 04260381963509 | Luxamed | Luxamed GmbH & Co. KG | ERA | 2026-08-26 |
| 04260381964353 | Luxamed | Luxamed GmbH & Co. KG | ERA | 2026-08-26 |
| 04260381964360 | Luxamed | Luxamed GmbH & Co. KG | ERA | 2026-08-26 |
| 04260381964377 | Luxamed | Luxamed GmbH & Co. KG | ERA | 2026-08-26 |
| 05713315012341 | Aurical Otocam 300-III | Natus Medical Denmark ApS | ERA | 2026-07-20 |
| 06972545090485 | Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | ERA | 2026-07-17 |
| 16972545090154 | Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | ERA | 2026-07-17 |
| 04260154547271 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547400 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547417 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547424 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547448 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547455 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547462 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547479 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547486 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547493 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 04260154547530 | OTOPRONT | Happersberger Otopront GmbH | ERA | 2026-07-08 |
| 16972545090017 | Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | ERA | 2026-05-18 |
| 16972545090031 | Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | ERA | 2026-05-18 |
| 00050428029497 | CVS | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ERA | 2026-02-13 |
| KTS0025716 | K.T.Surgico | K.T.SURGICO | ERA | 2024-07-24 |
| 00311917035000 | Walgreens | WALGREEN CO. | ERA | 2023-11-01 |
| 20884392954455 | Safety 1st | DOREL JUVENILE GROUP, INC. | ERA | 2023-10-15 |
| 10884389104514 | Medline | MEDLINE INDUSTRIES, INC. | ERA | 2023-01-21 |