FDA UDI
In Commercial Distribution
🇺🇸 United States
VuMAX HD Ophthalmic Ultrasound System
DI: 00896100002248
·
Model: VuMAX HD A/UBM
·
SONOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VuMAX HD Ophthalmic Ultrasound System
- Primary DI
- 00896100002248
- Version / Model
- VuMAX HD A/UBM
- Catalog Number
- AU.575
- Company Name
- SONOMED, INC.
- Labeler DUNS
- 107037079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 00ff99ca-064b-440f-870a-854fe98a4177
Device Description
The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes.The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. The system operates on a computer-based platform. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the multi-frequency ultrasound system base unit, 22" LCD, water-path probe with 35 MHz transducer, 10 MHz A-probe, keyboard and mouse, USB foot switch, immersion cups and user manual.
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
- Yes
- 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 |
|---|---|---|---|---|
| 11389 | Ophthalmic ultrasound imaging system | An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00896100002248 | GS1 |
Customer Contacts
- Phone
- 800-227-1285
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060626 | 000 |