Device
The HMS-5000-6-MINI-QUADRO is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments which are pressurized wi...
Manufacturer
Hyperbaric Modular Systems Inc.
Hyperbaric Modular Systems Inc.
Model: HMS-5000-6
DI: 00860006478988
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
The HMS-5000-6-MINI-QUADRO is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments which are pressurized with air used for administering hyperbaric oxygen therapy treatments up to six (6) patients simultaneously at a pressure up to 3 atmospheres absolute (3ATA). It is designed, fabricated, and tested in compliance with the following FDA consensus standards: American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cfc5e066-2955-4cf1-a9cc-3de5537b1f5a
Distribution Status:
In Commercial Distribution
DUNS Number:
831644005
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00860006478988
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00860006478919
Item #2 - Device ID Type:
Previous
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 12061
Name: Hyperbaric chamber, stationary
Definition:
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FDA Product Codes
CBF
Chamber, Hyperbaric
Premarket Submissions
Submission Number:
K152223
Supplement Number:
000