Summit to Sea

GUDID 00866115000317

SUMMIT TO SEA, LLC

Hyperbaric chamber, portable

• Primary Device ID: 00866115000317
• NIH Device Record Key: 058553af-c9aa-4ba2-bd33-ca11c4ff3cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summit to Sea
• Version Model Number: The Shallow Dive Hyperbaric Chamber
• Company DUNS: 013140518
• Company Name: SUMMIT TO SEA, LLC
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00866115000317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072757

FDA Product Code

• CBF: Chamber, Hyperbaric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-27

On-Brand Devices [Summit to Sea]

• 00866115000324: The Grand Dive Hyperbaric Chamber
• 00866115000317: The Shallow Dive Hyperbaric Chamber
• 00866115000300: The Dive Hyperbaric Chamber