FDA UDI
In Commercial Distribution
🇺🇸 United States
Hub - Refurbished
DI: 09353278000199
·
Model: R005324
·
ECHONOUS, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hub - Refurbished
- Primary DI
- 09353278000199
- Version / Model
- R005324
- Company Name
- ECHONOUS, INC.
- Labeler DUNS
- 080481089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-20
- Public Version
- 3
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 13e45555-8875-43ae-8f9c-aa2a5c44c6eb
Device Description
An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32547 | Medical networking interface unit | An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn. | No | Active |
| 62345 | Ultrasound imaging system multi-transducer connection unit | An electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held US transducers so the user can conveniently switch between transducers as required. It is a unit with multiple transducer ports and is typically attached to the US imaging system stand. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09353278000199 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181574 | 000 |