FDA.reportPublic FDA data

Parasol Patient Fall Prevention System

Primary DI
00854636006291
Brand
Parasol Patient Fall Prevention System
Company
Parasol Medical, LLC
Model
SC6S3
Device description
30 Day Chair Pad with 3 Foot Cord
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KMIMONITOR, BED PATIENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMIMonitor, Bed PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854636006291PrimaryGS10
50854636006296Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854636006291008546360062918546360062910854636006291
5085463600629650854636006296

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair occupant movement pressure/vibration 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length14Inch
Width7Inch

Regulatory Flags#

DUNS number
079786058
Device count
50
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854636006543Parasol Patient Fall Prevention SystemWB012022-12-07
00854636006550Parasol Patient Fall Prevention SystemWB022022-12-07
00854636006505Parasol Wireless Patient Fall Prevention SystemBP022022-12-07
00854636006512Parasol Patient Fall Prevention SystemBP012022-12-07
00854636006475Parasol Wireless Patient Fall Prevention SystemWSB2022-12-07
00854636006567Parasol Patient Fall Prevention SystemSSBWV2022-12-07
00854636006277Parasol Patient Fall Prevention SystemSC6S152022-12-07
00854636006284Parasol Patient Fall Prevention SystemSC6L82022-12-07
00854636006307Parasol Patient Fall Prevention SystemSC6L122022-12-07
00854636006321Parasol Patient Fall Prevention SystemSB6L82022-12-07
00854636006338Parasol Patient Fall Prevention SystemSP6S32022-12-07
00854636006345Parasol Patient Fall Prevention SystemSB6L8902022-12-07
00854636006352Parasol Patient Fall Prevention SystemSC6S3902022-12-07
00854636006659Parasol Wireless Patient Fall Prevention SystemWC302022-12-07
00854636006666Parasol Wireless Patient Fall Prevention SystemWB302022-12-07
00854636006673Parasol Wireless Patient Fall Prevention SystemWP302022-12-07
00854636006451Parasol drySmart Real-Time Incontinence Monitoring PadWDS-60902022-12-07
00854636006468Parasol drySmart Real-Time Incontinence Monitoring PadWDS-80902022-12-07
00854636006260Parasol Patient Fall Prevention SystemPADS-002022-12-07
50854636006272Parasol Patient Fall Prevention SystemSC6S152022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618125192328POSEYTIDI PRODUCTS, LLCKMI2025-12-04
00840828195348ANTI-SLIP, GRIP PAD FOR SENSOR PADS,10PKCURBELL MEDICAL PRODUCTS, INC.KMI2025-11-05
00840828195102FM UNDER-MATTERSS KIT-CORDEDCURBELL MEDICAL PRODUCTS, INC.KMI2025-09-10
00850064210163Central Hub CMSSibel Health Inc.KMI2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.KMI2025-03-27
00850064210002ANNE Chest Sensor KitSibel Health Inc.KMI2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.KMI2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.KMI2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.KMI2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.KMI2025-03-26
00850064210132ANNE View Patient MonitorSibel Health Inc.KMI2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.KMI2025-03-26
10080196373239MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
00080196750118MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
10193489001921MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-28
10193489036633MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-10-25
00023601033048CAREX HEALTH BRANDSDrive Devilbiss HealthcareKMI2024-09-30
00023601033055CAREX HEALTH BRANDSDrive Devilbiss HealthcareKMI2024-09-30
00840828192149UNI BED SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
00618125191406PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191413PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191420PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191437PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191444PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191451PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191468PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191499PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191505PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191512PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191529PoseyTIDI PRODUCTS, LLCKMI2024-05-03