HMS-2000

GUDID 00860006478940

The HMS-2000 is a Class A, single compartment pressure vessel for human occupancy (PVHO) that is oriented in a vertical cylindrical geometry. The HMS-2000 hyperbaric chamber family of products is designed with non-dedicated seating, providing flexibility in managing seating arrangements. The diameter of the HMS-2000 varies in size; thereby enabling the ability to increase the patient capacity from three (3) to four (4) seated patients. An extension nozzle is attached to the chamber hull which provides the unique capability to treat one (1) patient in the supine versus seated position. The maximum allowable working pressure is three (3) Atmospheres Absolute (ATA) (~29.4psi). The control and operation of the HMS-2000 is performed from a hull mounted control console. The HMS-2000 multiplace hyperbaric chamber 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.

Hyperbaric Modular Systems Inc.

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• Primary Device ID: 00860006478940
• NIH Device Record Key: f077a422-784a-4c08-832a-6d52cae7ea9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMS-2000
• Version Model Number: HMS-2000
• Company DUNS: 831644005
• Company Name: Hyperbaric Modular Systems Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006478940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011866

FDA Product Code

• CBF: Chamber, Hyperbaric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-10
• Device Publish Date: 2023-08-02

Devices Manufactured by Hyperbaric Modular Systems Inc.

• 00860006478940 - HMS-2000: 2023-08-10The HMS-2000 is a Class A, single compartment pressure vessel for human occupancy (PVHO) that is oriented in a vertical cylindrical geometry. The HMS-2000 hyperbaric chamber family of products is designed with non-dedicated seating, providing flexibility in managing seating arrangements. The diameter of the HMS-2000 varies in size; thereby enabling the ability to increase the patient capacity from three (3) to four (4) seated patients. An extension nozzle is attached to the chamber hull which provides the unique capability to treat one (1) patient in the supine versus seated position. The maximum allowable working pressure is three (3) Atmospheres Absolute (ATA) (~29.4psi). The control and operation of the HMS-2000 is performed from a hull mounted control console. The HMS-2000 multiplace hyperbaric chamber 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.
• 00860006478940 - HMS-2000: 2023-08-10 The HMS-2000 is a Class A, single compartment pressure vessel for human occupancy (PVHO) that is oriented in a vertical cylindri
• 00860006478964 - HMS-1000: 2023-08-10 The HMS-1000 hyperbaric chamber series is a Class B, monoplace hyperbaric chamber designed to treat one (1) patient to a maximum
• 00860006478926 - HMS-4000: 2023-08-09 The HMS-4000 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a horizontal cylindrical geometry. Con
• 00860006478902 - HMS-5000-COMPACT-QUADRO: 2022-11-08 The HMS-5000-12 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two