SideLyer SL01

GUDID 00860011685609

The SideLyer Adjustable Patient Bed (APB) is an AC-powered adjustable bed where the caregiver can adjust the bed position at various angles. The SideLyer APB supports patients who are in restricted positions or long term bed use due to lack of mobility or other issues. The APB is moveable, but can be locked in a stationary position. It has a padded horizontal surface and a flat padded vertical surface on one side so that patients can be positioned to lie on their side. The device may be rotated by the patient or caregiver using the device controller at different angles. The benefit of the SideLyer APB’s repositioning to the patient is to relieve or distribute pressure. Repositioning is a fundamental component of pressure ulcer prevention (PUP), including reducing or eliminating bedsores and decubitus ulcers. Repositioning also serves to increase blood flow and transcutaneous oxygen tension, reducing the likelihood of anoxic levels of oxygen and decrease localized interface pressure. Repositioning prevents complications such as pneumonia, joint contractures, and urinary tract infections.

THE SIDE LYER COMPANY, LLC

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Primary Device ID00860011685609
NIH Device Record Key12ff05e6-5d4c-44e8-bb67-abd5ca38d290
Commercial Distribution StatusIn Commercial Distribution
Brand NameSideLyer
Version Model NumberSLB01
Catalog NumberSL01
Company DUNS110139998
Company NameTHE SIDE LYER COMPANY, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com
Phone407-640-7722
Emailsupport@sidelyer.com

Device Dimensions

Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch
Height47 Inch
Depth34.75 Inch
Height85.25 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860011685609 [Primary]

FDA Product Code

IKZBed, Patient Rotation, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-07
Device Publish Date2024-04-29

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