FDA UDI
Not in Commercial Distribution
🇺🇸 United States
2-MHz Headset/Monitoring Transducer
DI: 00850681007023
·
Model: 40-00009
·
Novasignal Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 2-MHz Headset/Monitoring Transducer
- Primary DI
- 00850681007023
- Version / Model
- 40-00009
- Catalog Number
- NA - PRB2
- Company Name
- Novasignal Corp.
- Labeler DUNS
- 078766464
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-25
- Public Version
- 7
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 6939f523-1347-4c18-99c6-d50cbc47a8ac
- Distribution End Date
- 2020-12-08
Device Description
The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements. The transducer has the following specifications: • 2MHz ± 0.1MHz center frequency • 46mm ± 5mm focal length • 16mm active diameter • Fractional 6dB pulse-echo bandwidth = 60% to 80% • Round-trip insertion loss < 6dB • Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase
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
- 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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36970 | Noninvasive vascular ultrasound system probe | A hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). It may also be used to detect the foetal heartbeat. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850681007023 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160442 | 000 |