M210 Fall Monitor - M210 Fall Monitor - STANLEY SECURITY SOLUTIONS, INC.

Duns Number:196880520

Device Description: M210 Fall Monitor

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More Product Details

Catalog Number

M210

Brand Name

M210 Fall Monitor

Version/Model Number

M210

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)

-

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

KMI

Product Code Name

MONITOR, BED PATIENT

Device Record Status

Public Device Record Key

db864144-d621-4e28-b771-6fba42fa8644

Public Version Date

August 09, 2022

Public Version Number

2

DI Record Publish Date

March 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANLEY SECURITY SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 94