PocketECG IV – Unified Arrhythmia Diagnostic System - The battery type P4BA-AA-UNI is an accessory to - MEDICALGORITHMICS S A

Duns Number:522657576

Device Description: The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diag The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter.

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More Product Details

Catalog Number

-

Brand Name

PocketECG IV – Unified Arrhythmia Diagnostic System

Version/Model Number

P4BA-AB-UNI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K193104

Product Code Details

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Device Record Status

Public Device Record Key

7f85172e-0be2-4653-ae52-0d86bd6f443c

Public Version Date

August 24, 2020

Public Version Number

1

DI Record Publish Date

August 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICALGORITHMICS S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16