HMS-4000

GUDID 00860006478926

The HMS-4000 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a horizontal cylindrical geometry. Configurations vary from one (1) to three (3) compartments. These chambers are capable of administering hyperbaric oxygen therapy treatments to four (4) up to twenty-four (24) patients simultaneously. These chamber models comprise the HMS 4000 Horizontal Cylindrical Multiplace Hyperbaric Chamber System Product Family. Each system consists of a multiplace hyperbaric chamber with several major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Design pressures range from 3ATA (~29.4psi) up to 6ATA (~73.5psi). The HMS-4000 multiplace hyperbaric chamber 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.

Hyperbaric Modular Systems Inc.

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• Primary Device ID: 00860006478926
• NIH Device Record Key: a7717600-f7cf-4cb7-84ab-ac9ba3dd2e2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMS-4000
• Version Model Number: HMS-4000
• 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	00860006478926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163109

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: 2023-08-09
• Device Publish Date: 2023-08-01

Devices Manufactured by Hyperbaric Modular Systems Inc.

• 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: 2023-08-09The HMS-4000 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a horizontal cylindrical geometry. Configurations vary from one (1) to three (3) compartments. These chambers are capable of administering hyperbaric oxygen therapy treatments to four (4) up to twenty-four (24) patients simultaneously. These chamber models comprise the HMS 4000 Horizontal Cylindrical Multiplace Hyperbaric Chamber System Product Family. Each system consists of a multiplace hyperbaric chamber with several major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Design pressures range from 3ATA (~29.4psi) up to 6ATA (~73.5psi). The HMS-4000 multiplace hyperbaric chamber 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.
• 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