MONITOR,PROFESSIONAL,TABS, CE - MONITOR,PROFESSIONAL,TABS, CE - STANLEY SECURITY SOLUTIONS, INC.

Duns Number:196880520

Device Description: MONITOR,PROFESSIONAL,TABS, CE

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More Product Details

Catalog Number

-

Brand Name

MONITOR,PROFESSIONAL,TABS, CE

Version/Model Number

25022CE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 14, 2021

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

6d42d54f-de08-45ae-a628-f518d054c16c

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

July 29, 2021

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