SideLyer

Primary DI
00860011685609
Brand
SideLyer
Company
THE SIDE LYER COMPANY, LLC
Model
SLB01
Catalog number
SL01
Device description
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.
Published
2024-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKZBed, Patient Rotation, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKZBed, Patient Rotation, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011685609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011685609008600116856098600116856090860011685609

GMDN Terms#

Term, Definition table
TermDefinition
Kinetic bedA mains electricity (AC-powered) bed designed to enable continuous change of the patient's lying position, e.g., it can tilt the entire bed mattress support system (this includes the mattress, the framework that supports the mattress, and the bedding) lengthways, sideways or to a near vertical tilt; the patient will be secured in such extreme position. The bed is used for the treatment of critically ill patients who are immobilized, often during ventilator treatment, in order to prevent oedema, improve circulation, and prevent bedsores; it is also used for patients with severe back problems. It may have an integrated weighing scale.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth34.75Inch
Height47Inch
Height85.25Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
407-640-7722support@sidelyer.com

Regulatory Flags#

DUNS number
110139998
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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