EleGARD

Primary DI
B716DEVELG003
Brand
EleGARD
Company
Advancedcpr Solutions LLC
Model
SYSELG003
Catalog number
SYSELG003
Device description
The EleGARD 3.0 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® ChestCompression System or ARM XR Automated Chest Compressor.
Published
2023-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DMRSolution, M-Nitrophenol, Specific Reagent For Cholinesterase
FOABoard, Cardiopulmonary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DMRSolution, M-Nitrophenol, Specific Reagent For CholinesteraseClinical Toxicology1
FOABoard, CardiopulmonaryGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221901000EleGARDAdvancedcpr Solutions, LLC2022-07-29FOA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B716DEVELG003PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, reusableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763-259-3722Complaint@elevatedcpr.com

Regulatory Flags#

DUNS number
080313560
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B716DEVELG002EleGARDSYSELG002SYSELG0022022-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B716DEVELG002EleGARDAdvancedcpr Solutions LLCFOA2022-08-29
B716DEVELG002EleGARDAdvancedcpr Solutions LLCDMR2022-08-29
14026704662583HUDSON RCITELEFLEX INCORPORATEDFOA2019-08-07
04026704582228HUDSON RCITELEFLEX INCORPORATEDFOA2018-09-15