FDA.reportPublic FDA data

Smart Caregiver

Primary DI
00812293010969
Brand
Smart Caregiver
Company
Smart Caregiver Corporation
Model
GBR1-SYS
Device description
FallGuard CordLess monitor with bed pad
Published
2022-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00812293010969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812293010969008122930109698122930109690812293010969

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850043155072Cubby BedsSensory Medical, Inc.KMI2026-03-16
00199874390529Nightwatch Bedroom ModuleLutso Inc.KMI2026-03-06
05000223503956LEAFSMITH & NEPHEW MEDICAL LIMITEDKMI2026-03-03
05000223503994LEAFSMITH & NEPHEW MEDICAL LIMITEDKMI2026-03-01
10618125192325POSEYTIDI PRODUCTS, LLCKMI2025-12-04
00840828195416UNDER BED LIGHT CONTROLLER ASSEMBLYCURBELL MEDICAL PRODUCTS, INC.KMI2025-11-25
00840948103339Securitas HealthcareSecuritas Healthcare LLCKMI2025-09-26
00840948103346Securitas HealthcareSecuritas Healthcare LLCKMI2025-09-26
00860007550263Cubby BedsSensory Medical, Inc.KMI2025-01-31
20080196373236MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
40080196750116MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
20193489001928MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-28
00840828193405SAFE MOBILITY LIGHT KIT,XMIT,PAD,PWR 8'CURBELL MEDICAL PRODUCTS, INC.KMI2024-11-08
10193489001648MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-08
00840948103285Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103292Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103308Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103315Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103322Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
20193489036630MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-10-25
00190676007653PoseyPOSEY PRODUCTS, LLCKMI2024-10-23
30023601033049CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.KMI2024-09-30
30023601033056CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.KMI2024-09-30
00840828192712UNDER BED LIGHT CONTROLLER ASSEMBLYCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-22
10197344103744MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-07-22
00840828192132UNI CHAIR SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
10840828192146UNI BED SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
04719873790050BriteMED Technology Inc.BRITEMED TECHNOLOGY INC.KMI2024-06-04
00850064651034Bed4Foresite Healthcare, LLCKMI2024-05-24
00850064651072Bed4Foresite Healthcare, LLCKMI2024-05-24