FDA.reportPublic FDA data

Posey

Primary DI
10190676008336
Brand
Posey
Company
POSEY PRODUCTS, LLC
Model
8283WL
Device description
Wireless Bed and Stretcher Sensor Pad
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00190676008339Direct MarkingGS10
20190676008333PackageGS130In Commercial Distribution
10190676008336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190676008339001906760083391906760083390190676008339
2019067600833320190676008333
1019067600833610190676008336

GMDN Terms#

Term, Definition table
TermDefinition
Patient-monitoring bed mattress coverA device shaped to fit over a bed mattress and intended to monitor the status of patient movement in relation to the bed while providing comfort for the patient in bed. It consists of soft, waterproof textiles with built-in light sensors/optical cable(s) to detect patient movement and connects to a control unit which interfaces with a healthcare monitoring/call system to signal an alarm situation. It may be used to prevent falls over the bedrails, provide monitoring of patient movement/breathing, and/or monitor patient presence/absence. It is treated with an antibacterial agent to inhibit bacterial growth on the cover and can be laundered for cleaning. This is a reusable device.

Regulatory Flags#

DUNS number
008503294
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
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
30618125134718Grip-Lok3400LFC-10PK2024-12-02
10190676005632POSEYV2531V25312022-10-05
10190676005656POSEYV2550V25502022-10-05
10190676005663POSEYV2551V25512022-10-05
10190676005670POSEYV2811V28112022-10-05
10190676005687POSEYV2816V28162022-10-05
10190676005694POSEYV2819V28192022-10-05
10190676006301POSEYV8309ELV8309EL2022-10-06
10190676006318POSEYV8309V83092022-10-06
10190676001924POSEY EYE PROTECTORS46442022-08-04
10190676001948POSEY464646462022-10-06
10190676003867POSEY833383332022-10-06
10190676003874POSEY831683162022-10-05
10190676004383POSEY833283322022-10-06
10190676005649POSEYV2532V25322022-10-05
10190676006295POSEYV8283V82832022-10-06
10190676006516POSEY621862182022-10-06
10618125190666POSEY8334WL8334WL2022-11-02
10190676002013POSEY820882082022-10-04
10190676002020POSEY827682762022-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327694819VisionSTRYKER CORPORATIONKMI2026-06-22
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
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