Bariatric Homecare Bed Rail

Basic Information

• Brand Name: Bariatric Homecare Bed Rail
• Primary DI: 00616784046624
• Version / Model: 10466
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-05-19
• Public Version: 1
• Public Version Date: 2018-06-19
• Public Version Status: New
• Public Device Record Key: 2ff97e54-03d1-418b-95b9-9506e7d46f7e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	880.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34868	Bedrail	A rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616784046624	GS1
Unit of Use	00616784046617	GS1