Flow-Safe II+ BiLevel Disposable CPAP System

GUDID 30641043574045

MERCURY ENTERPRISES, INC.

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• Primary Device ID: 30641043574045
• NIH Device Record Key: 1c80a93d-ebe2-48b4-80d5-d44d5bb0b000
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flow-Safe II+ BiLevel Disposable CPAP System
• Version Model Number: 10-57404
• Company DUNS: 032705659
• Company Name: MERCURY ENTERPRISES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10641043574041 [Primary]
GS1	30641043574045 [Package]; Contains: 10641043574041; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090710

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

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: 2021-01-22
• Device Publish Date: 2021-01-14

On-Brand Devices [Flow-Safe II+ BiLevel Disposable CPAP System]

• 10641043574065: 10-57406
• 30641043574052: 10-57405
• 30641043574045: 10-57404