FDA.reportPublic FDA data

Posey

Primary DI
00190676007653
Brand
Posey
Company
POSEY PRODUCTS, LLC
Model
8309WL
Catalog number
8309WL
Device description
ON CUE PRO WIRELESS CHAIR PAD, TAP-2-PAIR
Published
2024-10-23
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
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
10190676007650PackageGS11In Commercial Distribution
20190676007657PackageGS130In Commercial Distribution
00190676007653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019067600765010190676007650
2019067600765720190676007657
00190676007653001906760076531906760076530190676007653

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
10190676008336Posey8283WL2026-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828197069US MATT PAD-UNI-CONNECT-NO LOGOCURBELL MEDICAL PRODUCTS, INC.KMI2026-10-15
10190676008336PoseyPOSEY PRODUCTS, LLCKMI2026-09-24
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCURBELL MEDICAL PRODUCTS, INC.KMI2026-07-23
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
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
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