FDA UDI
In Commercial Distribution
🇺🇸 United States
Norav 1200 Series PC-ECG
DI: 07290110252618
·
Model: SW H1
·
NORAV MEDICAL LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Norav 1200 Series PC-ECG
- Primary DI
- 07290110252618
- Version / Model
- SW H1
- Catalog Number
- HASP-SW-K-H1-01
- Company Name
- NORAV MEDICAL LTD.
- Labeler DUNS
- 514773159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-01
- Public Version
- 1
- Public Version Date
- 2019-10-09
- Public Version Status
- New
- Public Device Record Key
- be91de14-2db8-45f5-8d02-fa0abc460319
Device Description
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - H1 = Heart Rate Variability Analysis The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59086 | Cardiovascular risk evaluation interpretive software | An interpretive software program intended to be used in the assessment of risk/probability for having a cardiovascular condition (e.g., significant coronary stenosis) or event (e.g., heart attack, ischemic stroke, unstable angina, coronary revascularization). It typically combines some of the following data: patient demographics, physical measurements, symptoms, medical history, results of the qualitative/quantitative clinical specimen in vitro diagnostic (IVD) tests. It typically creates a risk score or probability that may be used to guide patient management. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290110252618 | GS1 |
Customer Contacts
- Phone
- +97249893001
- [email protected]