Home GUDID 53915187499900 Hyperbox System
Primary DI 53915187499900
Brand Hyperbox System
Company AOTI LIMITED
Model Hyperbox Homecare System
Catalog number G00001-2
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, venou
Published 2017-07-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name KPJ Chamber, Oxygen, Topical, Extremity
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KPJ Chamber, Oxygen, Topical, Extremity General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 53915187499900 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 53915187499900 53915187499900
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 14 Degrees Fahrenheit 140 Degrees Fahrenheit
Regulatory Flags# DUNS number 896654477 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05391518740027 Hyperbox System Hyperbox System, 115VAC G00002 2017-07-17 05391518749990 Hyperbox System Hyperbox Homecare System G00001-2 2017-07-05 53915187400272 Hyperbox System Hyperbox System, 115VAC G00002 2017-07-17
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05060371000356 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2025-12-12 05060371000370 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2025-12-12 00851404004015 OxySpur® Oxygen Diffusion Dressing Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004022 OxySpur® Oxygen Diffusion Dressing Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004039 OxySpur® Oxygen Diffusion Dressing Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004046 OxySpur® Oxygen Diffusion Dressing Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004060 OxyGeni® Humidicant Pack Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004077 OxyGeni® Dual Port cannula Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004084 OxyGeni® Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004091 OxySpur® Oxygen Diffusion Dressing Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004107 OxySpur® lite Oxygen Diffusion Dressing Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004114 OxyGeni® Oxygen Delivery Extension Set Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00851404004121 OxySpur® lite Oxygen Diffusion Dressings Electrochemical Oxygen Concepts, Inc. KPJ 2023-07-24 00860010630600 Numobag Kit Numotech, Inc. KPJ 2023-07-11 00855526003079 EPIFLO® Ogenix KPJ 2023-06-08 00855526003086 EPIFLO® Ogenix KPJ 2023-06-08 05060371000387 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2022-03-08 05060371000349 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2020-07-20 05060371000363 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2020-07-20 05060371000288 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2019-06-06 05060371000325 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2019-06-06 05060371000165 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2019-03-01 05060371000172 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2019-03-01 05060371000202 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2019-03-01 05060371000233 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2019-03-01 05060371000004 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2018-10-05 05060371000028 NATROX® Oxygen Wound Therapy INOTEC AMD LIMITED KPJ 2018-10-05 05391518740027 Hyperbox System AOTI LIMITED KPJ 2017-07-17 53915187400272 Hyperbox System AOTI LIMITED KPJ 2017-07-17 05391518749990 Hyperbox System AOTI LIMITED KPJ 2017-07-05