FDA UDI
In Commercial Distribution
🇺🇸 United States
Norav 1200 Series PC-ECG
DI: 07290110254995
·
Model: SW NH301-4
·
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
- 07290110254995
- Version / Model
- SW NH301-4
- Catalog Number
- HASP-SW-K-NH301-4-04
- Company Name
- NORAV MEDICAL LTD.
- Labeler DUNS
- 514773159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-02
- Public Version
- 1
- Public Version Date
- 2019-10-10
- Public Version Status
- New
- Public Device Record Key
- 81ec6763-0c9a-4f0a-9f01-3f99b6b347c7
Device Description
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis - Support for data transfer via USB or SD Card Reader (for DL800/900 recorders) 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 |
|---|---|---|---|---|
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36827 | Electrocardiographic long-term ambulatory recording analyser | An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290110254995 | GS1 |
Customer Contacts
- Phone
- +97249893001
- [email protected]