HMS-5000-COMPACT-QUADRO

GUDID 00860006478902

The HMS-5000-12 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments and is capable of administering hyperbaric oxygen therapy treatments up to twelve (12) patients simultaneously. It is one of the models contained within the HMS 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family. It is comprised of a multiplace hyperbaric chamber with a number of major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Pressures up to 6ATA (~73.5psi). The HMS-5000 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.

Hyperbaric chamber, stationary

• Primary Device ID: 00860006478902
• NIH Device Record Key: 9f85450e-f0da-473a-94e3-209272c02d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMS-5000-COMPACT-QUADRO
• Version Model Number: HMS-5000-12
• 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	00860006478902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152223

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: 2022-11-08
• Device Publish Date: 2022-10-31

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: 2023-08-09 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: 2022-11-08The HMS-5000-12 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments and is capable of administering hyperbaric oxygen therapy treatments up to twelve (12) patients simultaneously. It is one of the models contained within the HMS 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family. It is comprised of a multiplace hyperbaric chamber with a number of major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Pressures up to 6ATA (~73.5psi). The HMS-5000 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.
• 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