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PCCI Hyperbaric Systems

FDA UDI

Class II (US FDA UDI)

by Pcci Hyperbaric Systems

Identity

Trade Name
PCCI Hyperbaric Systems FDA UDI
Generic Name
Hyperbaric chamber, stationary FDA UDI
Device Name
The Althea 4200 chamber system is a monoplace hyperbaric chamber outfitted with a large round door. The chamber is pressurized with air, and oxygen is delivered via hood or mask. Pressure and depressurization controls can either be operated manually or automatically. The chamber includes an intercom system that allows two-way communication between the operator and the patient. The chamber is designed to fit through a commonly available 48” doorway. FDA UDI
Model / Reference
Althea 4200 FDA UDI
Description
The Althea 4200 chamber system is a monoplace hyperbaric chamber outfitted with a large round door. The chamber is pressurized with air, and oxygen is delivered via hood or mask. Pressure and depressurization controls can either be operated manually or automatically. The chamber includes an intercom system that allows two-way communication between the operator and the patient. The chamber is designed to fit through a commonly available 48” doorway. FDA UDI

Identifiers

Primary DI / UDI-DI
00850011262016 FDA UDI
510(k) Number
K102831 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

No

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hyperbaric chamber, stationary

PCCI Hyperbaric Systems by Pcci Hyperbaric Systems — 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
Pcci Hyperbaric Systems

Sources (1)

  • FDA UDI 9ff704c3-be70-4b83-8c47-009aa9aa3f3e 34 fields · synced Jun 8, 2026