ROOM CONTROLLER, UNIV. DOME LT., TC120 - ROOM CONTROLLER, UNIV. DOME LT., TC120 - STANLEY SECURITY SOLUTIONS, INC.

Duns Number:196880520

Device Description: ROOM CONTROLLER, UNIV. DOME LT., TC120

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More Product Details

Catalog Number

LI122UN

Brand Name

ROOM CONTROLLER, UNIV. DOME LT., TC120

Version/Model Number

LI122UN

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

IQA

Product Code Name

SYSTEM, ENVIRONMENTAL CONTROL, POWERED

Device Record Status

Public Device Record Key

083419ee-38c5-4bd7-be4a-59905329c020

Public Version Date

December 15, 2021

Public Version Number

1

DI Record Publish Date

December 07, 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