FDA.reportPublic FDA data

Posey

Primary DI
00816317024048
Brand
Posey
Company
RENU MEDICAL, INC
Model
RM-8309EL
Device description
Chair Sensor Pad 8309EL
Published
2022-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PJOFall Prevention Alarm/Sensor Combination Attached Or Unattached

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJOFall Prevention Alarm/Sensor Combination Attached Or UnattachedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816317024045PackageGS16In Commercial Distribution
00816317024048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631702404510816317024045
00816317024048008163170240488163170240480816317024048

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair occupant movement pressure/vibration 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.

Regulatory Flags#

DUNS number
100439103
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816317024420Kendall DVT SleeveRM-830222026-01-27
00816317024437Kendall DVT SleeveRM-830232026-01-27
00816317024444Kendall DVT SleeveRM-830242026-01-27
10816317024427Kendall DVT SleeveRM-830222026-01-27
10816317024434Kendall DVT SleeveRM-830232026-01-27
10816317024441Kendall DVT SleeveRM-830242026-01-27
00816317024413HoverMatt Lateral Transfer MatRM-HM34SPU-SPLIT-B2025-10-30
00816317023997Nellcor Pulse Oximeter ProbeRM-MAX-P2025-07-08
10816317023994Nellcor Pulse Oximeter ProbeRM-MAX-P2025-07-08
00816317024307Kendall ECG LeadsRM-33136R362025-05-01
00816317024321Kendall ECG LeadsRM-33136RT722025-05-01
00816317024338Kendall ECG LeadsRM-33136RT362025-05-01
00816317024345Kendall ECG LeadsRM-33137T2025-05-01
00816317024352Kendall ECG LeadsRM-331132025-05-01
00816317024369Kendall ECG LeadsRM-33154T2025-05-01
00816317024291Kendall ECG LeadsRM-33114N2025-05-01
10816317024304Kendall ECG LeadsRM-33136R362025-05-01
00816317024314Kendall ECG LeadsRM-33136R722025-05-01
10816317024328Kendall ECG LeadsRM-33136RT722025-05-01
10816317024335Kendall ECG LeadsRM-33136RT362025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05745001037000Teton Fall DetectionTeton.AI ApSPJO2025-01-01
04719889980032Cognito HealthCognito Health Inc.PJO2022-11-25
04719889980049Cognito HealthCognito Health Inc.PJO2022-11-25
04719889980025Cognito HealthCognito Health Inc.PJO2022-11-25
14719889980039Cognito HealthCognito Health Inc.PJO2022-11-25
14719889980046Cognito HealthCognito Health Inc.PJO2022-11-25
04719889980056Cognito HealthCognito Health Inc.PJO2022-11-25
00816317024031Posey RENU MEDICAL, INCPJO2022-08-18
10816317024038Posey RENU MEDICAL, INCPJO2022-08-18
10816317024045PoseyRENU MEDICAL, INCPJO2022-08-18
B4841140530FALL FIGHTER,STRING MONITORCrest Healthcare SupplyPJO2018-07-20