FDA.report

ROOM CONTROLLER, BLUE+WHITE DOME LIGHTS, TC120

Primary DI
00812664023697
Brand
ROOM CONTROLLER, BLUE+WHITE DOME LIGHTS, TC120
Company
STANLEY SECURITY SOLUTIONS, INC.
Model
LI122BL
Catalog number
LI122BL
Device description
ROOM CONTROLLER, BLUE+WHITE DOME LIGHTS, TC120
Published
2021-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IQASYSTEM, ENVIRONMENTAL CONTROL, POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812664023697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812664023697008126640236978126640236970812664023697

GMDN Terms

TermDefinition
Nurse call system alarmAn electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)380-8883Support_all@sbdinc.com

Regulatory Flags

DUNS number
196880520
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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