EleGARD

Basic Information

• Brand Name: EleGARD
• Primary DI: B716DEVELG002
• Version / Model: SYSELG002
• Catalog Number: SYSELG002
• Company Name: Advancedcpr Solutions LLC
• Labeler DUNS: 080313560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-29
• Public Version: 1
• Public Version Date: 2022-09-06
• Public Version Status: New
• Public Device Record Key: 612ef578-2522-4a4d-92a4-4400e60ca78a

Device Description

The EleGARD Patient Positioning System is a portable tool designed to elevate a patient’s head and thorax. It can be used to help maintain the sniffing position. There are three different adjustable head and neck angle positions. The EleGARD can be used whenever elevation of the head and thorax is clinically indicated, including during CPR and patient transport. The EleGARD can be used during manual CPR, manual active compression decompression CPR (ResQCPR™ System), and CPR with the LUCAS® Chest Compression System or ARM XR Automated Chest Compressor.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
DMR	Solution, M-Nitrophenol, Specific Reagent For Cholinesterase	Clinical Toxicology	862.3240	1
FOA	Board, Cardiopulmonary	General Hospital	880.6080	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58878	Freestanding patient positioner, reusable	A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B716DEVELG002	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191689	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity