Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200W (UDI: 07290110252076) - NORAV MEDICAL LTD.

Duns Number:514773159

Device Description: Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Input cable with ten leads AHA type and Clip connectors; Waiste Belt for mounting the wireless transmitter at Patient's hip.

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More Product Details

Catalog Number

1200W2-K-00-U-C10-17

Brand Name

Norav 1200 Series PC-ECG

Version/Model Number

1200W Kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MWI

Product Code Name

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

Device Record Status

Public Device Record Key

ca6ff0a3-927e-45c9-8a6e-6311f0659c02

Public Version Date

October 07, 2019

Public Version Number

1

DI Record Publish Date

September 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORAV MEDICAL LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 213