AincA®

Basic Information

• Brand Name: AincA®
• Primary DI: B00500199MRI0
• Version / Model: 00-199-MRI
• Catalog Number: 00-199-MRI
• Company Name: ANESTHESIA ASSOCIATES, INC.
• Labeler DUNS: 002065670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 1
• Public Version Date: 2021-04-08
• Public Version Status: New
• Public Device Record Key: 5e0f4c5c-f5b2-4476-8406-5d026cc4d698

Device Description

Manometer, Pressure, MRI Cond 3T, -40 to +80 cm H2O, 1/4" NPT-M Bottom-Mount, 2.5"Dia, Front Zero-Adj

Device Characteristics

• Single Use: No
• 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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
Primary	B00500199MRI0	HIBCC

Customer Contacts

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