ARMEDICA

Basic Information

• Brand Name: ARMEDICA
• Primary DI: B866MAMSX10651
• Version / Model: AMSX1065
• Catalog Number: AMSX1065
• Company Name: ARMEDICA MANUFACTURING CORP.
• Labeler DUNS: 018941711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-18
• Public Version: 1
• Public Version Date: 2022-11-28
• Public Version Status: New
• Public Device Record Key: 0603a84b-10ad-4f5d-b703-53e2f7f7ad34

Device Description

STEEL, ELECTRIC, X FRAME, ONE SECTION, 27 IN WIDE CHANGING TABLE WITH RESTRAINT BELT AND CASTERS

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
INQ	Table, Powered	Physical Medicine	890.3760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43694	Nappy changing table, portable	A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a foldable frame with legs designed to support an infant, child or an adult during nappy (diaper) changing. The device is used primarily for a patient with a disability who is incontinent and requires regular changing of their nappies. It is designed to be portable for transport to different locations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B866MAMSX10651	HIBCC