DEVICE: HMS-1000 (00860006478964)

Device Identifier (DI) Information

HMS-1000
HMS-1000
In Commercial Distribution

Hyperbaric Modular Systems Inc.
00860006478964
GS1

1
831644005 *Terms of Use
The HMS-1000 hyperbaric chamber series is a Class B, monoplace hyperbaric chamber designed to treat one (1) patient to a maximum operating pressure of three (3) Atmospheres Absolute (ATA) (~ 29.4 psi). The chamber uses 100% oxygen as both the pressurization and hyperbaric treatment gas. The overall external length of the horizontal cylinder configuration is 8.75 feet. Its internal diameter is 33.5 inches. It is constructed of acrylic, aluminum, and fine-grade steel. Single operator pressure control is achieved via a simple industrial Programmable Logic Device (PLD) controller. A low-voltage patient intercom provides communications between the patient in the chamber and the external chamber operators. HMS-1000 is designed, fabricated, and tested in compliance with the following FDA consensus standards: the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
12061 Hyperbaric chamber, stationary
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.
Active false
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FDA Product Code

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Product Code Product Code Name
CBF Chamber, Hyperbaric
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052866 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

92976fe8-6695-497c-af96-91b72aa64f9a
August 10, 2023
1
August 02, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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