FDA UDI
In Commercial Distribution
🇺🇸 United States
QAWeb Enterprise
DI: 05415334002449
·
Model: V2.xx
·
Barco NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QAWeb Enterprise
- Primary DI
- 05415334002449
- Version / Model
- V2.xx
- Catalog Number
- K5402901
- Company Name
- Barco NV
- Labeler DUNS
- 371618773
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-19
- Public Version
- 2
- Public Version Date
- 2021-04-28
- Public Version Status
- Update
- Public Device Record Key
- c3d24150-7a48-4f60-bac2-0ddcfb42703d
Device Description
QAWeb Enterprise Web Client
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| LHO | Instrument, quality-assurance, radiologic | Radiology | 892.1940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64325 | Radiology workstation display quality assurance software | A software application intended to be used to measure, calibrate, and adjust the display parameters of a radiology workstation monitor to standardize the quality level of digital radiological images (DICOM images) displayed by the monitor. It is typically used to manage the display quality of several computers within a healthcare facility, and to feed data (e.g., alerts) back to a central user(s). It is not intended for image processing, distribution, or viewing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415334002449 | GS1 |
Customer Contacts
- Phone
- +1(866)302-7939
- [email protected]