Soma Safe Enclosure

Basic Information

• Brand Name: Soma Safe Enclosure
• Primary DI: 00861402000407
• Version / Model: SSE 420
• Company Name: VIVAX MEDICAL CORPORATION
• Labeler DUNS: 154815062
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-04
• Public Version: 3
• Public Version Date: 2018-09-12
• Public Version Status: Update
• Public Device Record Key: 73f07cdb-501d-40dd-9c7b-2970367b932e

Device Description

Canopy afixed to frame encompassing a hospital bed preventing the patient from exiting without assistance

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
62826	Hospital bed confinement canopy	A fabric canopy intended to be affixed to a frame which encompasses a hospital bed to enclose a patient and thereby prevent the patient from exiting the bed without assistance. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00861402000407	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	40.5	Inch
Length	94.5	Inch
Height	57	Inch