FDA UDI
In Commercial Distribution
🇺🇸 United States
BresoDX1 BresoSensor Frame
DI: 00990008600039
·
Model: BTSM1-UF
·
BresoTec Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BresoDX1 BresoSensor Frame
- Primary DI
- 00990008600039
- Version / Model
- BTSM1-UF
- Company Name
- BresoTec Inc
- Labeler DUNS
- 203297148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-27
- Public Version
- 1
- Public Version Date
- 2023-07-05
- Public Version Status
- New
- Public Device Record Key
- f77e8c47-44a4-464d-8067-7cfad2594941
Device Description
BresoSensor Frame is a biocompatible component. BresoSensor Frame is a plastic holder with a medical grade adhesive on the patient’s contact side. BresoSensor Frame is used to hold BresoSensor on the suprasternal notch. During a test, BresoSensor Frame is intended to be in contact with the patient’s skin for a maximum period of 8 hours.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00990008600039 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220012 | 000 |