FDA UDI In Commercial Distribution 🇺🇸 United States

Wireless BT 12 lead resting ECG.

DI: 07290110250607 · Model: Blue ECG · NORAV MEDICAL LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Wireless BT 12 lead resting ECG.
Primary DI
07290110250607
Version / Model
Blue ECG
Catalog Number
BLUECG-D-00U-01
Company Name
NORAV MEDICAL LTD.
Labeler DUNS
514773159
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-21
Public Version
5
Public Version Date
2019-09-30
Public Version Status
Update
Public Device Record Key
074b5ac3-c62a-4c94-bf99-5f42a3e524f8

Device Description

Norav PC-ECG 1200 Series wireless Acquisition Device for Resting ECG with AHA type labelling.

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

GMDN Terms

Code Name
36367 Electrocardiography telemetric monitoring system transmitter

Identifiers

Type ID
Primary 07290110250607
Package 7290110250713

Customer Contacts

Phone
+97249893001