Catalog Number

1200W2-K-00-E-S10-01

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

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

MWI

Product Code Name

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

Public Device Record Key

7df4d432-82de-4557-a0eb-33da9da18fec

Public Version Date

September 30, 2019

Public Version Number

1

DI Record Publish Date

September 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-