Posey

Basic Information

• Brand Name: Posey
• Primary DI: 00816317024031
• Version / Model: RM-8309
• Company Name: RENU MEDICAL, INC
• Labeler DUNS: 100439103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-18
• Public Version: 3
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 48a22920-19c7-4060-8e63-a9b18cbf38ea

Device Description

Chair Sensor Pad 8309

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJO	Fall Prevention Alarm/Sensor Combination Attached Or Unattached	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35818	Bed/chair occupant movement pressure/vibration sensor	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816317024038	GS1	Case	6	In Commercial Distribution
Primary	00816317024031	GS1