Dale IV Armor

Basic Information

• Brand Name: Dale IV Armor
• Primary DI: 00817612020865
• Version / Model: 675
• Catalog Number: 675
• 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: 3
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: d3c09dad-a44e-4dd5-ad02-976820edbf7b

Device Description

Dale IV Armor, Flexible protective overlay, Fits most.

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: Labeling does not contain MRI Safety Information
• 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
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61139	Arm procedure positioner, single-use	A device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., to maintain the patency of an intravenous (IV) needle or an intravascular catheter]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and may be attached or fixed (e.g., onto a side rail). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817612020872	GS1	Box	10	In Commercial Distribution
Primary	00817612020865	GS1
Previous	H84106751	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry place