FDA.reportPublic FDA data

Smart Caregiver

Primary DI
00812293015131
Brand
Smart Caregiver
Company
Smart Caregiver Corporation
Model
TM-SMS
Device description
Transmitter
Published
2022-06-10
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
00812293015131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812293015131008122930151318122930151310812293015131

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory fall sensorA battery-powered electronic device intended to be worn on a patient’s body (e.g., in the form of a patch, pendant, wristband) to provide an alert signal for help when automatically activated in response to an event requiring need for assistance or care, typically in cases of falls or epileptic seizures. It consists of a sensor with a wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., phone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that urgent assistance is needed. It is intended to be used in the home and healthcare facility.

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