AccessGUDID - DEVICE: SideLyer (00860011685609)

GUDID

Device Identifier (DI) Information

Brand Name: SideLyer
Version or Model: SLB01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SL01
Company Name: THE SIDE LYER COMPANY, LLC

Primary DI Number: 00860011685609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 110139998 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37007	Kinetic bed	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKZ	Bed, Patient Rotation, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 41 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Height: 47 Inch
Depth: 34.75 Inch
Height: 85.25 Inch

Device Record Status

Public Device Record Key: 12ff05e6-5d4c-44e8-bb67-abd5ca38d290
Public Version Date: May 07, 2024
Public Version Number: 1
DI Record Publish Date: April 29, 2024