PCCI Hyperbaric Systems

GUDID 00850011262009

Hyperbaric Chamber System: Model 7806D Medical Air Lock, 78" diameter. Dual lock, rated for 6 persons in Main Lock and 2 persons in Entry Lock.

PCCI HYPERBARIC SYSTEMS

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• Primary Device ID: 00850011262009
• NIH Device Record Key: 26df4c54-b576-4f58-b328-96f12615b81d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCCI Hyperbaric Systems
• Version Model Number: 7806D Medical Air Lock
• 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	00850011262009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954387

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: 2023-08-15
• Device Publish Date: 2023-08-07