POSEY

Basic Information

• Brand Name: POSEY
• Primary DI: 10190676007933
• Version / Model: 8399SL
• Catalog Number: 8399SL
• Company Name: POSEY PRODUCTS, LLC
• Labeler DUNS: 008503294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-06
• Public Version: 1
• Public Version Date: 2022-10-14
• Public Version Status: New
• Public Device Record Key: 2ebe3cf4-f7af-4808-8809-d1336b99a86e

Device Description

8399 CHAIR ALARM BELT 3FT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KMI	Monitor, Bed Patient	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58773	Patient-monitoring bed mattress cover	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20190676007930	GS1	Case	24	In Commercial Distribution
Primary	10190676007933	GS1