FDA UDI
In Commercial Distribution
🇺🇸 United States
Portrait CVAXB
DI: 00198953024096
·
Model: CVAXB
·
Ge Medical Systems Information Technologies, Inc.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Portrait CVAXB
- Primary DI
- 00198953024096
- Version / Model
- CVAXB
- Catalog Number
- 5863721-12
- Company Name
- Ge Medical Systems Information Technologies, Inc.
- Labeler DUNS
- 118935631
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-10
- Public Version
- 1
- Public Version Date
- 2025-12-18
- Public Version Status
- New
- Public Device Record Key
- 08fd1446-2d06-4374-a650-53137643de05
Device Description
Portrait Central Viewer Application Installer V1.2.0
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
| MSX | System, Network And Communication, Physiological Monitors | Cardiovascular | 870.2300 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
| BZQ | Monitor, Breathing Frequency | Anesthesiology | 868.2375 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65832 | Wireless patient monitor/sensor reporting software, professional-only | A software program intended to be installed on an off-the-shelf, computerized device (e.g., desktop computer, tablet) and used by a healthcare professional in a clinical/care setting to receive data from a noninvasive, patient-worn, wireless monitor/sensor. It is not dedicated to bedside monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198953024096 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234130 | 000 |