Bubble Humidifier

GUDID 10709078014090

DRY BUBBLE HUMIDIFIER HIGH FLOW 6 - 20 LPM

WESTMED, INC.

Non-heated respiratory humidifier

• Primary Device ID: 10709078014090
• NIH Device Record Key: d95ed6ac-a90c-4bde-8587-87c8d6817ab6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bubble Humidifier
• Version Model Number: 1002283
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078014093 [Primary]
GS1	10709078014090 [Package]; Contains: 00709078014093; Package: [25 Units]; In Commercial Distribution

FDA Product Code

• KFZ: Humidifier, Non-Direct Patient Interface (Home-Use)

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: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [Bubble Humidifier]

• 00709078003158: Bubble Humidifier, Dry, High Flow
• 10709078007603: Bubble Humidifier, Dry
• 10709078014281: Concentrator Bubble Humidifier Elbow Adaptor
• 10709078014274: DRY BUBBLE HUMIDIFIER LOW FLOW Up To 6 LPM
• 10709078014090: DRY BUBBLE HUMIDIFIER HIGH FLOW 6 - 20 LPM