DEVICE: PAHI PAH-S1 Monoplace Hyperbaric Chamber (04719872000013)
Device Identifier (DI) Information
PAHI PAH-S1 Monoplace Hyperbaric Chamber
PAH-S1
In Commercial Distribution
PAN-AMERICA HYPERBARICS INC.
PAH-S1
In Commercial Distribution
PAN-AMERICA HYPERBARICS INC.
The PAH-SI Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses 100% oxygen as the pressurization gas and patient breathes the oxygen contained inside the chamber as the hyperbaric treatment gas.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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12061 | Hyperbaric chamber, stationary |
A 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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CBF | Chamber, Hyperbaric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K021693 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Max. Operating Pressure: 29.4 psig/3 ATA |
Device Record Status
14bab18c-88a9-433e-8219-c4bde3a8e06c
July 10, 2018
4
August 24, 2016
July 10, 2018
4
August 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(972)4230377
service@panamericahbo.com
service@panamericahbo.com