AQUESURE FILTER HUMIDIFIER OL-040419-U00

GUDID 20629160012605

Breathing circuit filter with built-in humidification

BOMImed Inc

Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 20629160012605
• NIH Device Record Key: b4d71bda-ca8e-4265-9b25-9834a7f581f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUESURE FILTER HUMIDIFIER
• Version Model Number: OL-040419-U00
• Catalog Number: OL-040419-U00
• Company DUNS: 248200149
• Company Name: BOMImed Inc
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com
• Phone: 800-667-6276
• Email: info@bomimed.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry area away from direct light

Device Identifiers

Device Issuing Agency	Device ID
GS1	10629160012608 [Primary]
GS1	20629160012605 [Package]; Contains: 10629160012608; Package: box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033008

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-28
• Device Publish Date: 2016-09-26

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• 20629160012605 - AQUESURE FILTER HUMIDIFIER: 2019-05-28Breathing circuit filter with built-in humidification
• 20629160012605 - AQUESURE FILTER HUMIDIFIER: 2019-05-28 Breathing circuit filter with built-in humidification