FDA UDI
In Commercial Distribution
🇺🇸 United States
CoroFlow Cardiovascular System
DI: 07350111070038
·
Model: 12000WW
·
COROVENTIS Research AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CoroFlow Cardiovascular System
- Primary DI
- 07350111070038
- Version / Model
- 12000WW
- Company Name
- COROVENTIS Research AB
- Labeler DUNS
- 352954840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-23
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- fdd01646-75e8-4395-a403-b05708570531
Device Description
CoroFlow Cardiovascular System is a system used to collect, calculate, present and store physiological parameters measured by Abbott Medical’s PressureWire X and Wi-box. Parameters include Pa, Pd, FFR, Pd/Pa, RFR, CFR, IMR, RRR, Absolute Flow, Absolute Resistance, dP/dt, PPG, intravascular temperature. CoroFlow Cardiovascular System is installed on a personal computer and receives measurement data wirelessly via the CoroHub Receiver. Information is displayed on the computers screen which can optionally be slaved to a monitor inside the coronary cathlab.
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
- Yes
- 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 |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10980 | Cardiac catheterization laboratory computer | A dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350111070038 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252238 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 525 – 795 Millimeter of Mercury
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 375 – 850 Millimeter of Mercury
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius