FDA.report

WIRELESS BED MONITOR, FALL FIGHTER, INOVONICS, PRINTED

Primary DI
B48411600710
Brand
WIRELESS BED MONITOR, FALL FIGHTER, INOVONICS, PRINTED
Company
Crest Healthcare Supply
Model
1160071
Device description
WIRELESS BED MONITOR, FALL FIGHTER, INOVONICS, PRINTED
Published
2020-09-29
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
PJPFall Prevention Alarm/Sensor Attached Only

Product Code Classifications

CodeDeviceSpecialtyClass
PJPFall Prevention Alarm/Sensor Attached OnlyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B48411600710PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
1-320-275-3382customerservice@cresthealthcare.com

Regulatory Flags

DUNS number
151772415
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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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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
B4841169540STATION,WIRELESS,MOMENTARY,1/4",SC,BLANK1169542024-12-12
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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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
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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
B4841154060SEAT 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