HMS-5000-6-MINI-QUADRO

Primary DI
00860006478988
Brand
HMS-5000-6-MINI-QUADRO
Company
Hyperbaric Modular Systems Inc.
Model
HMS-5000-6
Device description
The HMS-5000-6-MINI-QUADRO is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments which are pressurized with air used for administering hyperbaric oxygen therapy treatments up to six (6) patients simultaneously at a pressure up to 3 atmospheres absolute (3ATA). It 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.
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CBFChamber, Hyperbaric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBFChamber, HyperbaricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152223000Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc.2016-04-29CBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006478919PreviousGS10
00860006478988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006478919008600064789198600064789190860006478919
00860006478988008600064789888600064789880860006478988

GMDN Terms#

Term, Definition table
TermDefinition
Hyperbaric chamber, stationaryA 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.

Regulatory Flags#

DUNS number
831644005
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006478919HMS-5000HMS-5000-12-COMPACT-QUADRO2025-06-16
00860006478940HMS-2000 HMS-2000 2023-08-02
00860006478964HMS-1000HMS-10002023-08-02
00860006478926HMS-4000HMS-40002023-08-01
00860006478902HMS-5000-COMPACT-QUADROHMS-5000-122022-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860006478919HMS-5000Hyperbaric Modular Systems Inc.CBF2025-06-16
G625R800340Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-06-02
08906124943051TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
08906124943068TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
G623430US Hyperbaric NetworkUS Hyperbaric Network LLCCBF2025-05-02
00850052737009Sea-Long Medical HoodSea-Long Medical Systems LLCCBF2024-11-21
08906124941477TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-09-03
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B878430F0RevitalairOXAVITA S.R.L.CBF2024-01-19
08906124940012TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-01-10
08906124940005TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2023-09-29
00850011262009PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2023-08-07
00860006478940HMS-2000 Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478964HMS-1000Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478926HMS-4000Hyperbaric Modular Systems Inc.CBF2023-08-01
00860006478902HMS-5000-COMPACT-QUADROHyperbaric Modular Systems Inc.CBF2022-10-31
00852678007078Perry BaromedicalPERRY BAROMEDICAL CORPORATIONCBF2022-08-31
00852678007122BaramedPERRY BAROMEDICAL CORPORATIONCBF2022-08-31
00852682007996Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2022-08-29
00852682007941Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007958Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007934Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-05-01
00852834007065Newtowne HyperbaricsTYPHOON WATER WARES LTDCBF2020-03-13
00852682007903Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-02-01
00852682007927Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-02-01