PCCI Hyperbaric Systems

GUDID 00850011262016

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.

PCCI HYPERBARIC SYSTEMS

Hyperbaric chamber, stationary

• Primary Device ID: 00850011262016
• NIH Device Record Key: 9ff704c3-be70-4b83-8c47-009aa9aa3f3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCCI Hyperbaric Systems
• Version Model Number: Althea 4200
• Company DUNS: 016658080
• Company Name: PCCI HYPERBARIC SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011262016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102831

FDA Product Code

• CBF: Chamber, Hyperbaric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-22
• Device Publish Date: 2025-07-14

On-Brand Devices [PCCI Hyperbaric Systems]

• 00850011262009: Hyperbaric Chamber System: Model 7806D Medical Air Lock, 78" diameter. Dual lock, rated for 6 pe
• 00850011262016: The Althea 4200 chamber system is a monoplace hyperbaric chamber outfitted with a large round do