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Hms-5000

FDA UDI

Class II (US FDA UDI)

by Hyperbaric Modular Systems, Inc.

Identity

Trade Name
HMS-5000 FDA UDI
Generic Name
Hyperbaric chamber, stationary FDA UDI
Device Name
The HMS-5000-12-COMPACT-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 twelve (12) 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. FDA UDI
Model / Reference
HMS-5000-12-COMPACT-QUADRO FDA UDI
Description
The HMS-5000-12-COMPACT-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 twelve (12) 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860006478919 FDA UDI
510(k) Number
K152223 FDA UDI
FDA Product Code
CBF FDA UDI
GMDN Term
Hyperbaric chamber, stationary FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5470 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hyperbaric chamber, stationary

Hms-5000 by Hyperbaric Modular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hyperbaric chamber, stationary.

Cleared under the same submission

K152223 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hyperbaric Modular Systems, Inc.

Sources (1)

  • FDA UDI 573c26fc-d285-493d-ad40-467638d3e196 34 fields · synced Jun 6, 2026