FDA UDI
In Commercial Distribution
🇺🇸 United States
BB-613P Chest-Monitor 40-Unit Multipack
DI: 17290020154009
·
Model: 2.1.0
·
BIOBEAT TECHNOLOGIES LTD
Product Codes
6
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
Basic Information
- Brand Name
- BB-613P Chest-Monitor 40-Unit Multipack
- Primary DI
- 17290020154009
- Version / Model
- 2.1.0
- Catalog Number
- BB90000200040
- Company Name
- BIOBEAT TECHNOLOGIES LTD
- Labeler DUNS
- 532193771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2025-03-05
- Public Version
- 1
- Public Version Date
- 2025-03-13
- Public Version Status
- New
- Public Device Record Key
- f9186f70-f430-4888-a435-1145ab46e132
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
| BZQ | Monitor, Breathing Frequency | Anesthesiology | 868.2375 | 2 |
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | Cardiovascular | 870.1435 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57960 | Multiple physiological parameter spot-check system, clinical | An electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17290020154009 | GS1 | ||||
| Unit of Use | 07290020154002 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222010 | 000 |