FDA.reportPublic FDA data

Posey

Primary DI
10816317024045
Brand
Posey
Company
RENU MEDICAL, INC
Model
RM-8309EL
Device description
Chair Sensor Pad 8309EL
Published
2022-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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 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
100439103
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 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
00816317024048PoseyRENU MEDICAL, INCPJO2022-08-18
10816317024038Posey RENU MEDICAL, INCPJO2022-08-18
B4841140530FALL FIGHTER,STRING MONITORCrest Healthcare SupplyPJO2018-07-20