FDA UDI
In Commercial Distribution
🇺🇸 United States
Finapres
DI: 08719327007105
·
Model: Finapres NOVA Main Unit NC
·
Finapres Medical Systems B.V.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Finapres
- Primary DI
- 08719327007105
- Version / Model
- Finapres NOVA Main Unit NC
- Catalog Number
- FP_910804
- Company Name
- Finapres Medical Systems B.V.
- Labeler DUNS
- 489470686
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-30
- Public Version
- 1
- Public Version Date
- 2018-12-31
- Public Version Status
- New
- Public Device Record Key
- de82daae-8433-48be-9582-c4c74d97164d
Device Description
Finapres NOVA Main Unit NC
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
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| DSB | Plethysmograph, Impedance | Cardiovascular | 870.2770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36551 | Patient monitoring system module, blood pressure, noninvasive | A small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719327007105 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173916 | 000 |