FDA UDI
In Commercial Distribution
🇺🇸 United States
ComboMap Pressure and Flow System
DI: 00845225010874
·
Model: 6800
·
VOLCANO CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ComboMap Pressure and Flow System
- Primary DI
- 00845225010874
- Version / Model
- 6800
- Catalog Number
- 802745001
- Company Name
- VOLCANO CORPORATION
- Labeler DUNS
- 135179237
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-08
- Public Version
- 7
- Public Version Date
- 2022-01-26
- Public Version Status
- Update
- Public Device Record Key
- 44758c28-79b3-49d4-9e2b-63583f3d5c66
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | 870.1200 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47485 | Intravascular haemodynamic monitoring system | An assembly of devices used for the continuous in vivo measurement and display of blood pressure and blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. It typically includes a vascular pressure/flow measuring guidewire equipped with transducers/sensors at its working end, a computer with a touchscreen monitor to display the readings, and alarms; it may also include an electrocardiograph (ECG) input, a printer, and a remote control. The system is used to obtain haemodynamic information for the diagnosis and treatment of blood vessel disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845225010874 | GS1 |