Bubble Humidifier

GUDID 00616784570136

DYNAREX CORPORATION

Heat/moisture exchanger, single-use

• Primary Device ID: 00616784570136
• NIH Device Record Key: 94559ee9-47bc-4f31-9777-4c60fe0d54d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bubble Humidifier
• Version Model Number: 5701
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 50
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00616784570112 [Unit of Use]
GS1	00616784570136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923946

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

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: 2016-09-24

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