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 ID00860006478902
NIH Device Record Key9f85450e-f0da-473a-94e3-209272c02d56
Commercial Distribution StatusIn Commercial Distribution
Brand NameHMS-5000-COMPACT-QUADRO
Version Model NumberHMS-5000-12
Company DUNS831644005
Company NameHyperbaric Modular Systems Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860006478902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBFChamber, Hyperbaric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-08
Device Publish Date2022-10-31

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-10002023-08-10 The HMS-1000 hyperbaric chamber series is a Class B, monoplace hyperbaric chamber designed to treat one (1) patient to a maximum
00860006478926 - HMS-40002023-08-09 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-QUADRO2022-11-08The 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-QUADRO2022-11-08 The HMS-5000-12 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two

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