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PAHI PAH-S1 Monoplace Hyperbaric Chamber

FDA UDI

Class II (US FDA UDI)

by Pan-America Hyperbarics, Inc.

Identity

Trade Name
PAHI PAH-S1 Monoplace Hyperbaric Chamber FDA UDI
Generic Name
Hyperbaric chamber, stationary FDA UDI
Device Name
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. FDA UDI
Model / Reference
PAH-S1 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
04719872000013 FDA UDI
510(k) Number
K021693 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

PAHI PAH-S1 Monoplace Hyperbaric Chamber by Pan-America Hyperbarics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hyperbaric chamber, stationary.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pan-America Hyperbarics, Inc.

Sources (1)

  • FDA UDI 14bab18c-88a9-433e-8219-c4bde3a8e06c 36 fields · synced May 31, 2026