Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200M (UDI: 07290110250812) - NORAV MEDICAL LTD.

Duns Number:514773159

Device Description: Kit includes: PC-ECG 1200M (UDI: 07290110250812) for Stress-Test ECG with AHA type labelli Kit includes: PC-ECG 1200M (UDI: 07290110250812) for Stress-Test ECG with AHA type labelling; Input Cable with 10 Patient Leads AHA Type and Snap Connectors.Special edition for Device Technologies Australia

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More Product Details

Catalog Number

1200S-K-00-U-S10-06

Brand Name

Norav 1200 Series PC-ECG

Version/Model Number

1200S 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

24bba240-f6cd-42d8-9d61-d4cfd7dff5e3

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