FDA.reportPublic FDA data

Smart Caregiver

Primary DI
00812293012413
Brand
Smart Caregiver
Company
Smart Caregiver Corporation
Model
PPB-WI
Device description
Sensor Pad
Published
2022-05-25
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
00812293012413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812293012413008122930124138122930124130812293012413

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

Regulatory Flags#

DUNS number
012082397
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812293010761Smart CaregiverSB90-SYS2022-05-27
00812293010778Smart CaregiverSBR1-SYS2022-05-27
00812293010785Smart CaregiverSBW1-SYS2022-05-27
00812293012222Smart CaregiverRP-BC1-SYS2022-05-27
00812293012246Smart CaregiverRP-BBR1-SYS2022-05-27
00812293012673Smart CaregiverDVBR1-SYS2022-05-27
00812293012697Smart CaregiverRP-GBT-RI2022-05-27
00812293012703Smart CaregiverRP-GCT-WI2022-05-27
00812293012741Smart CaregiverRPA-BCB1-SYS2022-05-27
00812293012901Smart CaregiverRP-WEBR1-SYS2022-05-27
00812293012918Smart CaregiverRP-WEC1-SYS2022-05-27
00812293012987Smart CaregiverRP-433FM7-SYS2022-05-27
00812293013199Smart CaregiverRP-433FM5-SYS2022-05-27
00812293013205Smart CaregiverRP-WEFM7-SYS2022-05-27
00812293013731Smart CaregiverRP-DVFM5-SYS2022-05-27
00812293013748Smart CaregiverRP-DVFM7-SYS2022-05-27
00812293013755Smart CaregiverRP-WEFM5-SYS2022-05-27
00812293014028Smart CaregiverRP-GBR1-SYS2022-05-27
00812293014035Smart CaregiverRP- GC1-SYS2022-05-27
00812293014332Smart CaregiverRP-EFM7-SYS2022-05-27

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