ViSi Mobile System Package 5-lead AAMI

Trade name

ViSi Mobile System Package

Generic name

General-purpose multi-parameter bedside monitor

Model / Ref / Catalog

5-lead AAMI, 92-10094

Primary DI / UDI-DI

00850733007117

FDA product code

MHX

GMDN term

General-purpose multi-parameter bedside monitor

Device class

Class II

Regulation number

870.1025

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: General-purpose multi-parameter bedside monitor

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• ViSi Disposable Wrist Cradle, Small (Qty 20)

  Class II

  FDA 510(k) K152341 Active Cleared 14 Dec 2015 GUDID on market

• ViSi Mobile Monitor, Single Band, Refurbished

  Class II

  FDA 510(k) K152341 Active Cleared 14 Dec 2015 GUDID on market

• ViSi Cuff Module

  Class II

  FDA 510(k) K152341 Active Cleared 14 Dec 2015 GUDID on market

• ViSi Disposable Adult Cuff, Medium+ (Qty 20)

  Class II

  FDA 510(k) K152341 Active Cleared 14 Dec 2015 GUDID on market

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