FDA.reportPublic FDA data

Parasol Wireless Patient Fall Prevention System

Primary DI
00854636006642
Brand
Parasol Wireless Patient Fall Prevention System
Company
Parasol Medical, LLC
Model
KEY01
Device description
Wireless Falls Monitor ID Key
Published
2022-12-07
Public version status
New
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
00854636006642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854636006642008546360066428546360066420854636006642

GMDN Terms#

Term, Definition table
TermDefinition
Inpatient motion surveillance unitAn electrically-powered device designed to be used in a healthcare or assisted living setting to track the movements of an inpatient/resident for capture of high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall risk) and to automatically send alert notifications to healthcare staff via a central monitoring station. It includes one or more cameras and a processing unit intended to detect, record, and transmit high-risk events based on predetermined motion threshold references.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079786058
Device count
1
Premarket exempt
true
Manufacturing date on label
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
00854636006291Parasol Patient Fall Prevention SystemSC6S32022-12-07
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

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