Hyperbox System

Basic Information

• Brand Name: Hyperbox System
• Primary DI: 05391518749990
• Version / Model: Hyperbox Homecare System
• Catalog Number: G00001-2
• Company Name: AOTI LIMITED
• Labeler DUNS: 896654477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-05
• Public Version: 3
• Public Version Date: 2020-06-24
• Public Version Status: Update
• Public Device Record Key: 41e851b1-a69e-4de1-b0f2-50e6d6f7c5a5

Device Description

The Hyper-Box Homecare System is intended to be used for the treatment of acute and chronic wounds, such as; o skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions o decubitus ulcers o amputations/infected stumps o skin grafts o burns o frostbite The device can be used in hospitals, nursing homes, clinics, as well as at the patient's home as an adjunct to standard wound therapy.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	878.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47189	Extremity-oxygenation hyperbaric chamber, powered	A small, mains electricity (AC-powered) device intended to hermetically surround a patient's limb for the topical application of oxygen (O2) from a O2 supply, usually humidified, at a pressure slightly greater than atmospheric (e.g., 1 to 2 atm) during hyperbaric oxygen therapy (HBOT). The O2-enriched atmosphere may be raised above normal pressure by the device either continuously or intermittently. The device is typically a rigid plastic shell with electronic controls or a flexible shell connected to controls, tubing, and other accessories. It is typically used to treat skin ulcerations, decubitus ulcers, infected stumps, skin grafts, burns, and frostbite.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391518749990	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 140 Degrees Fahrenheit