FDA UDI
In Commercial Distribution
🇺🇸 United States
MELODY
DI: 03770015437012
·
Model: MELODY PATIENT
·
ADVANCED ECHO TECHNOLOGY
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MELODY
- Primary DI
- 03770015437012
- Version / Model
- MELODY PATIENT
- Company Name
- ADVANCED ECHO TECHNOLOGY
- Labeler DUNS
- 260110102
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-24
- Public Version
- 1
- Public Version Date
- 2022-02-01
- Public Version Status
- New
- Public Device Record Key
- 698f1456-ee70-4a41-b40b-5772ec3d24d5
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63383 | Video consultation telemedicine system | A electrically-powered device designed for use in telemedicine to provide real-time and interactive transmission of images and sound between two or more sites, enabling a healthcare professional to communicate with other professionals or directly with a patient. It consists of VDU, camera, speaker, and headphone components that may be integrated (or attached to) a mobile or hand-held unit which has rechargeable batteries, or as components that can be connected to a television; there may be optional accessories to provide additional functionality (e.g., stethoscope). It can be used within or between healthcare facilities, or a professional facility and the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03770015437012 | GS1 |
Customer Contacts
- Phone
- +33967174746
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161354 | 000 |