FDA UDI
In Commercial Distribution
🇺🇸 United States
PORTRAIT RRP01
DI: 00195278223401
·
Model: RRP01
·
GE Healthcare Finland Oy
Product Codes
5
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PORTRAIT RRP01
- Primary DI
- 00195278223401
- Version / Model
- RRP01
- Catalog Number
- 5514119
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-12
- Public Version
- 2
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- ac985d79-488f-47b9-a60b-fd86330adf8f
Device Description
BODY-WORN RESP ELECTRODE PATCH
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | Cardiovascular | 870.2300 | 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 |
|---|---|---|---|---|
| 61679 | Thoracic electrical impedance electrode array, single-use | A noninvasive configuration of multiple electrodes (e.g., patches, belt-like) intended to be affixed to the thorax to perform continuous bioimpedance measurements for assessment of lung function (e.g., respiratory rate) or pulmonary conditions (e.g., atelectasis, pneumothorax, endotracheal tube misplacement) of a ventilated or spontaneous breathing patient; it is intended to be used in conjunction with a parent device [e.g., monitor, thoracic electrical impedance tomography (EIT) or segmentography system]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00195278229229 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 00195278223401 | GS1 | ||||
| Package | 00195278699893 | GS1 | 30 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230626 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal