Flow-Safe Anti-Asphyxia Valve Elbow

GUDID 10641043571217

For use with Flow-Safe, Flow-Safe II, Flow-Safe IIEZ

MERCURY ENTERPRISES, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 10641043571217
• NIH Device Record Key: 7444bf73-2ff1-4bdd-af32-1a4c16748738
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flow-Safe Anti-Asphyxia Valve Elbow
• Version Model Number: 10-57121
• Company DUNS: 032705659
• Company Name: MERCURY ENTERPRISES, 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: false
• 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	10641043571217 [Primary]
GS1	30641043571211 [Package]; Package: [10 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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-24

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