FDA UDI In Commercial Distribution 🇺🇸 United States

Norav 1200 Series PC-ECG

DI: 07290110253752 · Model: 1200W1 · 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
07290110253752
Version / Model
1200W1
Catalog Number
1200W1-D-00E-01
Company Name
NORAV MEDICAL LTD.
Labeler DUNS
514773159
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-09-22
Public Version
1
Public Version Date
2019-09-30
Public Version Status
New
Public Device Record Key
623d1d3a-1b2a-4751-b532-2cb5b1bd9bf2

Device Description

PC-ECG Wireless Acquisition Device (Rev.01) for Stress-Test ECG with IEC type labelling

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
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
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

GMDN Terms

Code Name
36367 Electrocardiography telemetric monitoring system transmitter

Identifiers

Type ID
Primary 07290110253752

Customer Contacts

Phone
+97249893001