Dale Bendable Armboard

Basic Information

• Brand Name: Dale Bendable Armboard
• Primary DI: 00817612020346
• Version / Model: 653
• Catalog Number: 653
• Company Name: DALE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 001061233
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-19
• Public Version: 2
• Public Version Date: 2019-05-15
• Public Version Status: Update
• Public Device Record Key: 7aad538e-272d-4e59-a232-7e3235f75f99

Device Description

Dale Bendable Armboard, X-Small, 4.25" x 1"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10184	Armboard, reusable	A device designed to stabilize a patient's arm during an intervention or procedure typically to maintain the patency of an intravenous (IV) needle or an intravascular catheter. It is typically an elongated, flat surface of expanded polystyrene, wood, or artificial fibre board that is covered with a durable plastic or coating that can be easily cleaned. It may have a metal attachment so that it can be affixed to, e.g., an operating/examination table, a blood donor couch, or a chair, or it may be placed on a flat surface (e.g., on top of an operating/examination table). This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817612020353	GS1	Box	10	In Commercial Distribution
Primary	00817612020346	GS1
Previous	H84106531	HIBCC