MRI-Safe

Basic Information

• Brand Name: MRI-Safe
• Primary DI: 00840348526585
• Version / Model: NF-120
• Catalog Number: NF-120
• Company Name: AADCO MEDICAL, INC.
• Labeler DUNS: 153603204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-19
• Public Version: 1
• Public Version Date: 2022-12-27
• Public Version Status: New
• Public Device Record Key: ac8a0514-816b-4184-b364-77269616267c

Device Description

MRI-SAFE MANOMETER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KZF	Device, Medical Examination, Ac Powered	General Hospital	880.6320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17711	Medical device pressure test meter	An electrically-powered electronic instrument designed to measure and establish the degree of positive or negative pressure (pneumatic or hydraulic) found in a medical device, piece of equipment, or system. It is connected to the device, equipment, or system with the unknown pressure via a hose or connector and the pressure is sensed by this device and converted into a digital pressure reading displayed in one of several units, e.g., mmHg, cmH2O, or pascal. It is typically used by a healthcare provider (i.e., clinical technician) in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840348526585	GS1