HARMONICA 11205

GUDID 08054187381140

Harmonica is a wired digital video-otoscope that integrates a high-definition camera with chip-on-tip and a LED system.

INVENTIS SRL

Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct

• Primary Device ID: 08054187381140
• NIH Device Record Key: 40db5c64-c5b3-4224-9c82-a67ca069694c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARMONICA
• Version Model Number: HARMONICA
• Catalog Number: 11205
• Company DUNS: 338454995
• Company Name: INVENTIS SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054187381140 [Primary]

FDA Product Code

• ERA: Otoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-19
• Device Publish Date: 2023-12-11

Devices Manufactured by INVENTIS SRL

• 08054187381140 - HARMONICA: 2023-12-19Harmonica is a wired digital video-otoscope that integrates a high-definition camera with chip-on-tip and a LED system.
• 08054187381140 - HARMONICA: 2023-12-19 Harmonica is a wired digital video-otoscope that integrates a high-definition camera with chip-on-tip and a LED system.
• 08054187380020 - BELL: 2023-08-03 AUDIOMETER. Basic diagnostic audiometer, capable of performing fast and accurate air and bone conduction threshold examination.
• 08054187380044 - HARP: 2023-08-03 AUDIOMETER. Harp Basic is an advanced diagnostic audiometer, capable of performing speech and pure-tone audiometry, via air cond
• 08054187380051 - HARP: 2023-08-03 AUDIOMETER. Harp Basic is an advanced diagnostic audiometer, capable of performing speech and pure-tone audiometry, via air cond
• 08054187380068 - HARP: 2023-08-03 AUDIOMETER. Harp Plus is an advanced diagnostic audiometer, capable of performing: speech and pure-tone audiometry via air condu
• 08054187380075 - HARP: 2023-08-03 AUDIOMETER. Harp Plus is an advanced diagnostic audiometer, capable of performing: speech and pure-tone audiometry via air condu
• 08054187380082 - PIANO: 2023-08-03 AUDIOMETER. Piano Basic is an advanced clinical audiometer with two separate and independent channels. It is capable of performi
• 08054187380099 - PIANO: 2023-08-03 AUDIOMETER. Piano Basic is an advanced clinical audiometer with two separate and independent channels. It is capable of performi