Flow-Safe II Disposable CPAP System

GUDID 30641043572164

MERCURY ENTERPRISES, INC.

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 30641043572164
• NIH Device Record Key: c538cc62-c053-45d1-bad9-84b03d1d63cb
• Commercial Distribution Discontinuation: 2019-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flow-Safe II Disposable CPAP System
• Version Model Number: 10-57216
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10641043572160 [Primary]
GS1	30641043572164 [Package]; Contains: 10641043572160; Package: [5 Units]; Discontinued: 2019-12-31; 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: 4
• Public Version Date: 2019-12-06
• Device Publish Date: 2015-09-24

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

• 30641043572140: 10-57214
• 30641043572133: 10-57213
• 30641043572171: 10-57217
• 30641043572164: 10-57216
• 30641043572157: 10-57215