FDA.reportPublic FDA data

Wireless Bed Monitor, Inovonics

Primary DI
B4841160020
Brand
Wireless Bed Monitor, Inovonics
Company
Crest Healthcare Supply
Model
116002
Device description
Wireless Bed Monitor, Inovonics
Published
2018-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJPFall Prevention Alarm/Sensor Attached Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJPFall Prevention Alarm/Sensor Attached OnlyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B4841160020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair occupant movement sensorAn electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) designed to be placed under a bed and/or chair occupant to detect and/or measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair exit. Some types are able to detect in addition occupant respiration and heart rates; and some types function with an alarm/alert/notification system to indicate unattended occupant attempt to vacate bed/chair.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391542950003Kinesis QTUGKINESISPJP2023-02-22
05391542950010Kinesis GaitKINESISPJP2023-02-22
B48411600710WIRELESS BED MONITOR, FALL FIGHTER, INOVONICS, PRINTEDCrest Healthcare SupplyPJP2020-09-29
B4841160040BED PAD,FALL FIGHTER,1/4 RECPTCrest Healthcare SupplyPJP2018-07-18
B4841160050FALL FIGHTER,CHAIR PAD,1/4Crest Healthcare SupplyPJP2018-07-18
B4841144480MONITOR, CHAIR, FALL FIGHTER, W/CLIPCrest Healthcare SupplyPJP2017-08-31
B4841144490MONITOR, BED, FALL FIGHTER, W/CLIPCrest Healthcare SupplyPJP2017-08-31
B4841144500PAD,CHAIR,FALLFIGHTER,1YRCrest Healthcare SupplyPJP2017-08-31
B4841144510PAD,BED,FALLFIGHTER,1YRCrest Healthcare SupplyPJP2017-08-31
B4841145030PAD,CHAIR,FALLFIGHTER,60 DAYCrest Healthcare SupplyPJP2017-08-31
B4841145040PAD,BED,FALLFIGHTER,60 DAYCrest Healthcare SupplyPJP2017-08-31
B4841148510PAD,BED,VIG,1 YRCrest Healthcare SupplyPJP2017-08-31
B4841148520PAD,CHAIR,VIG,1 YRCrest Healthcare SupplyPJP2017-08-31
B4841153830MAT,FLOOR,FALL FIGHTER,GREYCrest Healthcare SupplyPJP2017-08-31
B4841153970MONITOR, INFRARED, FALL FIGHTERCrest Healthcare SupplyPJP2017-08-31
B4841154060"SEAT BELT ALARM, FALL FIGHTER, MEDIUM, 38"" - 48"""Crest Healthcare SupplyPJP2017-08-31
B4841154140SEAT BELT ALARM,FALL FIGHTER, LARGECrest Healthcare SupplyPJP2017-08-31
B4846711360PAD,BED,HD5, 1 YR, 10 PKCrest Healthcare SupplyPJP2017-08-31
B4846711540PAD,CHAIR,HDS,60 DAY,10PKCrest Healthcare SupplyPJP2017-08-31
B4846711580PAD,BED,HDS,60 DAY,10 PKCrest Healthcare SupplyPJP2017-08-31
B4846711750PAD,CHAIR,HDS,1 YR,10PKCrest Healthcare SupplyPJP2017-08-31
B4841139450CHAIR,SENTRY DELUXE MONITOR Crest Healthcare SupplyPJP2017-07-28
B4841139460CHAIR,SENTRY DELUXE MONITORCrest Healthcare SupplyPJP2017-07-28