PAHI PAH-S1 Monoplace Hyperbaric Chamber

Basic Information

• Brand Name: PAHI PAH-S1 Monoplace Hyperbaric Chamber
• Primary DI: 04719872000013
• Version / Model: PAH-S1
• Company Name: PAN-AMERICA HYPERBARICS INC.
• Labeler DUNS: 658755160
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 4
• Public Version Date: 2018-07-10
• Public Version Status: Update
• Public Device Record Key: 14bab18c-88a9-433e-8219-c4bde3a8e06c

Device Description

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBF	Chamber, Hyperbaric	Anesthesiology	868.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719872000013	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K021693	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Max. Operating Pressure: 29.4 psig/3 ATA