DEVICE: Norav 1200 Series PC-ECG (07290110255008)
Device Identifier (DI) Information
Norav 1200 Series PC-ECG
SW P-MP200
In Commercial Distribution
HASP-SW-K-P1-01
NORAV MEDICAL LTD.
SW P-MP200
In Commercial Distribution
HASP-SW-K-P1-01
NORAV MEDICAL LTD.
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- Driver for P-MP200 Thermal Printer
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
63034 | Thermal printer |
An electrically-powered printing device designed to use heat to print on paper; it is not intended to produce labels. It uses either direct thermal printing or thermal transfer printing.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
379818a7-b292-4ca2-9ce0-ae66a59fee98
June 10, 2022
2
October 02, 2019
June 10, 2022
2
October 02, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+97249893001
info@norav.com
info@norav.com