NA - ECG disposable electrodes with solid gel and SSC - FIAB SPA

Duns Number:439770017

Device Description: ECG disposable electrodes with solid gel and SSC sensor, round-shaped Ø 40mm, pre-gelled a ECG disposable electrodes with solid gel and SSC sensor, round-shaped Ø 40mm, pre-gelled and equipped with snap connection. F9070P model has features that make it absolutely reliable during signal recording with all different ECG on the market in stress tests and holter.

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More Product Details

Catalog Number

F9070P

Brand Name

NA

Version/Model Number

F9070P

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"

Yes

For Single-Use

Yes

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

DRX

Product Code Name

Electrode, Electrocardiograph

Device Record Status

Public Device Record Key

846ce16c-51dd-4822-bd9c-a9b8c32c381e

Public Version Date

November 18, 2020

Public Version Number

2

DI Record Publish Date

June 13, 2020

Additional Identifiers

Package DI Number

18033695726039

Quantity per Package

40

Contains DI Package

08033695726032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FIAB SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 42