FDA.reportPublic FDA data

STATION,PUSH FOR HELP,BLUE,EEI

Primary DI
B48430000090
Brand
STATION,PUSH FOR HELP,BLUE,EEI
Company
Crest Healthcare Supply
Model
3000009
Device description
Station, Push For Help, Blue, EEI
Published
2024-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B48430000090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call systemAn assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-320-275-3382customerservice@cresthealthcare.com

Regulatory Flags#

DUNS number
151772415
Device count
1
DM exempt
true
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B484DARPSM50094A0Elite Digital Pillow Speaker for Critical Alert, 8-pin DIN, Nurse, PTW, BeepDARPSM-50094AN/A2026-03-13
B4846600WX0CALL CORD,VALUECALL,SINGLE,UNV,1/4-2C,WHITE,7FT6600WXN/A2025-06-06
B484SC01YXD0SOFTCALL,CUSTOM,7PIN,8FTSC01YXD2025-06-06
B4840B111CPL0STATION,CRE/COR,SGL,1G,PLASTIC PLATEB111CPL2024-12-12
B484108086PL0ADAPTER,LATCHING STATION, (2) 1/4-2C,PLASTIC PLATE108086PL2024-12-12
B484108087PL0ADAPTER,LATCHING STATION, (2) 1/4-2C,W/POWER SUPP,PLASTIC PLATE108087PL2024-12-12
B4841169520CALL CORD,PUFFCALL ASSEMBLY,SGL,1/4 2C1169522024-12-12
B4841169540"STATION,WIRELESS,MOMENTARY,1/4"",SC,BLANK"1169542024-12-12
B484116955STATION,WIRELESS,ALERT,BLANK1169552024-12-12
B484116956STATION,WIRELESS,CHECK-IN,BLANK1169562024-12-12
B4841902269STATION,HELP,LIFELINE,9171C19022692024-12-12
B4841902271STATION,CHECK IN,LIFELINE,9171C19022712024-12-12
B48419022710STATION,CHECK IN,LIFELINE,9171C19022712024-12-12
B48419022720STATION,CALL CORD,LIFELINE,9171C19022722024-12-12
B48430000010CORRIDOR LIGHT,EEI30000012024-12-12
B48430000020AUDIO VISUAL PATIENT STATION,EEI30000022024-12-12
B48430000030VISUAL PATIENT STATION,EEI30000032024-12-12
B48430000060STATION,DUTY,EEI30000062024-12-12
B48430000070STATION,PUSH/PULL FOR HELP,NWP,EEI30000072024-12-12
B48430000080STATION,PUSH FOR HELP,RED,EEI30000082024-12-12

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00812664024892TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024908TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024915TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
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