NIFometer

GUDID 10641043340011

MERCURY ENTERPRISES, INC.

Airway pressure monitor, non-powered

• Primary Device ID: 10641043340011
• NIH Device Record Key: cf502522-1a14-4a0f-9d33-b457082c715c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIFometer
• Version Model Number: 10-34001
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10641043340011 [Primary]
GS1	30641043340015 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032593

FDA Product Code

• BXR: Meter, Airway Pressure (Inspiratory Force)

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: 2020-07-03
• Device Publish Date: 2016-04-01

On-Brand Devices [NIFometer]

• 30641043340039: 10-34003
• 30641043340022: 10-34002
• 10641043340011: 10-34001
• 30641043340008: 10-34000