Blue Diamond

Basic Information

• Brand Name: Blue Diamond
• Primary DI: 15060797551071
• Version / Model: BD0100-2580
• Catalog Number: BD0100-2580
• Company Name: David Scott Company
• Labeler DUNS: 073814568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-07
• Public Version: 1
• Public Version Date: 2022-07-15
• Public Version Status: New
• Public Device Record Key: 21852a57-69ad-45a6-974e-8993c5ac7546

Device Description

This Blue Diamond® Gel Pad is a pressure management pad. All our gel pads are made in the USA and are designed to mimic human adipose tissue composition to help prolong the chance of pressure insults. Because of the size of this pad it is ideal for Gel Wrap for 6" Peg Board Posts. 5" x 7" x 3/8" with Velcro® closures.

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: 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
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31684	Operating table patient pressure distribution pad, reusable	A cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060797551071	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	5	Inch
Length	7	Inch
Height	.375	Inch