Prevalon

Basic Information

• Brand Name: Prevalon
• Primary DI: 00618029980014
• Version / Model: 700-093
• Catalog Number: 700-093
• Company Name: SAGE PRODUCTS, LLC
• Labeler DUNS: 054326178
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-12
• Public Version: 2
• Public Version Date: 2022-07-26
• Public Version Status: Update
• Public Device Record Key: ae0520ce-b860-49a7-a2de-693385d2669b
• Distribution End Date: 2021-10-07

Device Description

TrendeMATS Mobile Air Transfer System for Trendelenburg Position

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
KME	BEDDING, DISPOSABLE, MEDICAL	General Hospital	880.6060	1
CCX	SUPPORT, PATIENT POSITION	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46148	Patient transfer system, manual	A wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance (i.e., without changing horizontal body position, lifting, rolling, or dragging). The device typically includes a patient-transfer mechanism (e.g., mechanical, hydraulic) easy to operate by an attendant with minimal physical effort. It is used in hospitals and other healthcare facilities to reduce injuries to both patients and staff while transferring non-ambulatory, comatose, or neurologically-injured patients between beds, tables, and/or stretchers.	No	Active
61850	Absorbent underpad, non-antimicrobial, single-use	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.	No	Active
62789	Operating table non-slip back pad	A non-slip cushioned pad, typically with a pressure-sensitive adhesive, intended to be placed between an operating table mattress and a patient’s back to secure the patient to the table and prevent them from sliding on the table top, typically while placing them in the Trendelenburg position or applying traction pulling forces on the legs during surgery; it may also be intended to aid in distributing patient body weight over a larger surface area and in preventing pressure sores and tissue necrosis on prominent parts of the body during the procedure. Additional securing devices [e.g., straps, adaptors, clamps] may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50618029980019	GS1	case	5	Not in Commercial Distribution	2021-10-07
Primary	00618029980014	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	39.0	Inch
Length	81.0	Inch