FDA.report

Posey

Primary DI
30817357022002
Brand
Posey
Company
HYGIA HEALTH SERVICES, INC.
Model
8307
Device description
Posey Single-Patient Use Bed Pad Over Mattress Sensor
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KMIMonitor, Bed Patient

Product Code Classifications

CodeDeviceSpecialtyClass
KMIMonitor, Bed PatientGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30817357022002PackageGS16In Commercial Distribution
10817357022008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3081735702200230817357022002
1081735702200810817357022008

GMDN Terms

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

Regulatory Flags

DUNS number
177939027
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
30817357020015NellcorMAX-A2016-09-24
30817357020022NellcorMAX-N2016-09-24
30817357020039Welch AllynSOFT-112016-09-29
30817357020046CritikonSFT-A2-2A-L2016-09-29
30817357020053Masimo18592016-09-24
30817357020060CritikonSFT-A2-2A2016-09-29
30817357020077MedlineMDS9723HP2016-09-24
30817357020084RegardR390482016-09-28
30817357020091Masimo23292016-09-24
30817357020107Welch AllynSOFT-11L2016-09-29
30817357020114Covidien331032016-09-30
30817357020121Aircast30402016-09-24
30817357020138HuntleighDVT 102016-09-24
30817357020145NellcorMAX-I2016-09-24
30817357020152CritikonSFT-A1-2A2016-09-29
30817357020169Kendall95292016-09-24
30817357020176Welch Allyn390482016-09-28
30817357020183Masimo18622016-09-24
30817357020190Cardinal Health30503-132016-09-28
30817357020206Covidien331142016-09-30

Other Devices Sharing Product Codes

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