FDA UDI
In Commercial Distribution
🇺🇸 United States
PORTRAIT RR P-RR01
DI: 00195278264817
·
Model: P-RR01
·
GE Healthcare Finland Oy
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PORTRAIT RR P-RR01
- Primary DI
- 00195278264817
- Version / Model
- P-RR01
- Catalog Number
- 2103567-001
- 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
- 6b201507-8e0a-402e-8d99-8d59cb6d7c22
Device Description
PORTRAIT RR P-RR 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 |
|---|---|---|---|---|
| DRG | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | Cardiovascular | 870.2910 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| MSX | System, network and communication, physiological monitors | Cardiovascular | 870.2300 | 2 |
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | Cardiovascular | 870.2300 | 2 |
| BZQ | Monitor, breathing frequency | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65830 | Respiration rate signal processor/transmitter | An electrically-powered device designed to be connected to a thorax-placed electrode array (not included) to collect, process, and wirelessly transmit respiration rate signal data for subsequent display on a separate monitor. It is a small unit with an electrical connection, internal processing functionality, and a transmitter. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195278264817 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230626 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius