EleGARD SYSELG003
GUDID B716DEVELG003
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® Chest Compression System or ARM XR Automated Chest Compressor.
Advancedcpr Solutions LLC
Freestanding patient positioner, reusable| Primary Device ID | B716DEVELG003 |
| NIH Device Record Key | 3e0347a5-4930-45be-b990-1338afcdd007 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EleGARD |
| Version Model Number | SYSELG003 |
| Catalog Number | SYSELG003 |
| Company DUNS | 080313560 |
| Company Name | Advancedcpr Solutions LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B716DEVELG003 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221901
FDA Product Code
| DMR | Solution, M-Nitrophenol, Specific Reagent For Cholinesterase |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-23 |
| Device Publish Date | 2023-11-15 |
On-Brand Devices [EleGARD]
| B716DEVELG002 | The EleGARD Patient Positioning System is a portable tool designed to elevate a patient’s head |
| B716DEVELG003 | The EleGARD 3.0 Patient Positioning System is a portable tool designed to elevate a patient’s |
Trademark Results [EleGARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELEGARD 88048084 not registered Live/Pending |
Minnesota Resuscitation Solutions LLC 2018-07-23 |
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