FDA.report

PAD,CHAIR,FALLFIGHTER,1YR

Primary DI
B4841144500
Brand
PAD,CHAIR,FALLFIGHTER,1YR
Company
Crest Healthcare Supply
Model
114450
Device description
PAD,CHAIR,FALLFIGHTER,1YEAR
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

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
B4841144500PrimaryHIBCC0

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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B484116956STATION,WIRELESS,CHECK-IN,BLANK1169562024-12-12
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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
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