35X80 Enmerse Gel Infused 2 way stretch Matt
Gel Foam - PVEN-3580FLNA2SZP
Device Description
A large, durable, fabric case filled with various densities of foam that support a gel structure, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: IKY
Device Name: Mattress, Flotation Therapy, Non-Powered
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HO
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5150
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 00810055884162
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A