ALLEN

Basic Information

• Brand Name: ALLEN
• Primary DI: 00615521015541
• Version / Model: 112004
• Catalog Number: GE5405554
• Company Name: ALLEN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 147805894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-31
• Public Version: 1
• Public Version Date: 2023-06-08
• Public Version Status: New
• Public Device Record Key: 66e2481e-c8ed-41d1-8662-1ba156ce3af4

Device Description

Armrest, EU GE Part Number: 5405554 007

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37047	Arm procedure positioner, reusable	A preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615521015541	GS1

Customer Contacts

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