POSEY

Basic Information

• Brand Name: POSEY
• Primary DI: 10190676000057
• Version / Model: 5701
• Catalog Number: 5701
• Company Name: POSEY PRODUCTS, LLC
• Labeler DUNS: 008503294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1d67ef77-c3da-4305-9df5-00b6e1a574e1

Device Description

ROLL GUARD REPLACEMENT

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
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	880.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35993	Bedrail pad	A device which is formed as a flat or contoured fitted cushion made of soft, non-irritating materials designed to protect the patient from coming into contact with the bedrails and inadvertently hurting or injuring themselves. It will be mainly used for patients that have little self-control, infants and very young children. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20190676000054	GS1	CS	6	In Commercial Distribution
Primary	10190676000057	GS1
Direct Marking	00190676000050	GS1