Manometer

Basic Information

• Brand Name: Manometer
• Primary DI: 10641043553787
• Version / Model: 10-55378
• Company Name: MERCURY ENTERPRISES, INC.
• Labeler DUNS: 032705659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-15
• Public Version: 3
• Public Version Date: 2020-04-09
• Public Version Status: Update
• Public Device Record Key: 1674a049-d313-46de-8b74-1bb9e1b9cf74

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	868.2600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46634	Airway pressure monitor, non-powered	A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30641043553781	GS1		280	In Commercial Distribution
Primary	10641043553787	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K954486	000