FDA UDI
In Commercial Distribution
🇺🇸 United States
PORTRAIT HSWXB
DI: 00195278697165
·
Model: HSWXB
·
GE Healthcare Finland Oy
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PORTRAIT HSWXB
- Primary DI
- 00195278697165
- Version / Model
- HSWXB
- Catalog Number
- 5700219-11
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-30
- Public Version
- 1
- Public Version Date
- 2024-05-08
- Public Version Status
- New
- Public Device Record Key
- 8727f277-8bcc-44ae-96b5-7720893e5226
Device Description
Portrait HSWXB Medical Software
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 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| MSX | System, network and communication, physiological monitors | Cardiovascular | 870.2300 | 2 |
| BZQ | Monitor, breathing frequency | Anesthesiology | 868.2375 | 2 |
| DRG | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | Cardiovascular | 870.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66625 | Physiologic monitor-installed software | An application software program intended to be installed on a dedicated monitoring device (i.e., software in a medical device), to process and display real-time patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] to facilitate data viewing, management, and communication in a clinical setting. It may in addition notify clinicians of events, patients at risk, and/or manage workflows. It is not intended for intraoperative/intraprocedural monitoring and is neither dedicated to neonatal nor obstetrical monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195278697165 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234130 | 000 |