Immersus

Basic Information

• Brand Name: Immersus
• Primary DI: 00850016369161
• Version / Model: Replacement Cover 42"x84"x6"
• Catalog Number: 2302
• Company Name: IMMERSUS HEALTH COMPANY, LLC
• Labeler DUNS: 080627691
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-21
• Public Version: 1
• Public Version Date: 2020-03-02
• Public Version Status: New
• Public Device Record Key: d4d0db76-c381-4e5e-977e-87ae8b06f654
• Distribution End Date: 2040-02-19

Device Description

2302 Replacement Cover for Immersus Mattress 42"x84"x6"

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: Yes
• 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
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	880.5150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63237	Foam bed mattress	A large, durable, fabric case filled with foam, which may be segmented/compartmentalised, 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. It may contain weight-distribution air cells. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850016369161	GS1