Cosyfit Hi-Lo Profiling Standard

Basic Information

• Brand Name: Cosyfit Hi-Lo Profiling Standard
• Primary DI: 05060631842610
• Version / Model: 183cm x 91cm - 122cm sides
• Catalog Number: SR191120
• Company Name: SAFESPACES (CORNHOLME) LIMITED
• Labeler DUNS: 349371893
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-12
• Public Version: 1
• Public Version Date: 2025-11-20
• Public Version Status: New
• Public Device Record Key: 02148340-c0f0-4e27-b0ce-8abc72ce66a1

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: Yes
• Has Lot/Batch Number: No
• 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
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	880.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65683	Safe environment patient enclosure	A freestanding, framed, tent-like structure designed to be constructed on site to function as a temporary enclosure for safe playing, resting or sleeping, typically for a patient with autism, epilepsy, challenging behaviours and/or learning difficulties. It has a soft fabric/plastic interior with padded regions to prevent injury, and a limiting and low-stimulation environment. It can be used in the home or during travel for a patient of any age. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060631842610	GS1