DEVICE: PAHI PAH-S1 Monoplace Hyperbaric Chamber (04719872000013)

Download: XML | JSON

Device Identifier (DI) Information

PAHI PAH-S1 Monoplace Hyperbaric Chamber
PAH-S1

PAN-AMERICA HYPERBARICS INC.
04719872000013
GS1
1
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.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CBF Chamber, Hyperbaric
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Max. Operating Pressure: 29.4 psig/3 ATA
CLOSE

Device Status

In Commercial Distribution
August 24, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
(972)2359331
service@panamericahbo.com
CLOSE