MRI-Safe

Basic Information

• Brand Name: MRI-Safe
• Primary DI: 00840348526608
• Version / Model: NF-130
• Catalog Number: NF-130
• 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: aae41b9e-cc87-4992-bd83-f4a37dabc134

Device Description

MRI-SAFE STEP STOOL W/HANDRAIL

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
FMR	Device, Transfer, Patient, Manual	General Hospital	880.6785	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42809	Assistive stool/step	A platform designed or adapted for a disabled person to stand upon to compensate for differences in height, to place the feet/legs upon for rest/support when seated, and/or to sit upon. It may include legs, hand rails, and/or suction cups to attach to a surface, and may be used inside, outside or in a bath. It may be used to facilitate comfort, to correct lower-limb positioning during a treatment, or to compensate for an injury, temporary or permanent disability. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840348526608	GS1