FDA UDI
In Commercial Distribution
🇺🇸 United States
SOMNOtouch RESP
DI: 04250413404612
·
Model: TOR050U
·
SOMNOmedics GmbH
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SOMNOtouch RESP
- Primary DI
- 04250413404612
- Version / Model
- TOR050U
- Catalog Number
- TOR050U
- Company Name
- SOMNOmedics GmbH
- Labeler DUNS
- 314112173
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-18
- Public Version
- 4
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- c0411ffc-3265-4f8e-b9d3-778f5001aa1a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| MNR | Ventilatory Effort Recorder | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62230 | Home-use sleep apnoea recording system | A battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea [e.g., obstructive sleep apnoea (OSA)]. It includes primary components such as sensors (e.g., air pressure sensor) and/or a control unit which may have some user-interface functionality, and typically additional devices which may include a gas sampling face mask and/or connecting leads/cables; collected data is transferred to a central database or computerized device. | No | Active |
| 13085 | Polygraph | A multichannel physiologic graphic recorder designed for the simultaneous recording of a number of different physiologic parameters, e.g., electrocardiogram (ECG), blood pressure, electroencephalogram (EEG), temperature or respiration. This device is frequently used for testing the truth of a person's statements (i.e., used as a "lie detector"). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250413404612 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140861 | 000 |