Alternating Pressure Recliner Overlay Family

Basic Information

• Brand Name: Alternating Pressure Recliner Overlay Family
• Primary DI: 00845699008087
• Version / Model: AP Recliner Overlay Family
• Company Name: SIZEWISE RENTALS, L.L.C.
• Labeler DUNS: 967025602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-02
• Public Version: 1
• Public Version Date: 2021-03-10
• Public Version Status: New
• Public Device Record Key: 198b1737-ecfe-4d20-8346-43cdaecaf805

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMR	Device, Transfer, Patient, Manual	General Hospital	880.6785	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44192	Alternating-pressure chair cushion, single-use	A pad intended to be placed on the seat of a chair and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's buttocks-chair contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845699008087	GS1