FDA UDI
In Commercial Distribution
🇺🇸 United States
PORTRAIT SpO2 P-W01
DI: 00195278264800
·
Model: P-W01
·
GE Healthcare Finland Oy
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PORTRAIT SpO2 P-W01
- Primary DI
- 00195278264800
- Version / Model
- P-W01
- Catalog Number
- 2096441-001
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-01
- Public Version
- 1
- Public Version Date
- 2023-09-11
- Public Version Status
- New
- Public Device Record Key
- 498ae565-8b4c-4386-9eb0-cf50ae55e8a5
Device Description
PORTRAIT SpO2 P-W FINAL DEVICE ASSEMBLY
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | Cardiovascular | 870.2300 | 2 |
| DRG | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | Cardiovascular | 870.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65829 | Pulse oximeter probe/processor | A photoelectric device designed to be applied externally to a body site (e.g., fingertip) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED), received by a photodetector, and processed to produce the measurements. The measurements are subsequently sent to an appropriate device for display (not included). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195278264800 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230626 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal