EasyBoost SPU Zipper Sheet with Side Handles

Basic Information

• Brand Name: EasyBoost SPU Zipper Sheet with Side Handles
• Primary DI: 00860004936879
• Version / Model: ESB-DIS-2027
• Company Name: Seneca Devices, Inc.
• Labeler DUNS: 117658378
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-17
• Public Version: 1
• Public Version Date: 2024-10-25
• Public Version Status: New
• Public Device Record Key: ebe0487e-fc37-4cf3-b608-7620c4c3e2cd

Device Description

Case of 12 Sheets with zipper and side handles for in-bed repositioning, Polyester fabric, 66" x 108"

Device Characteristics

• Single Use: Yes
• 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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
37165	Patient transfer/turning sheet, single-use	A manual device in the form of a non-inflatable sheet or mat intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860004936879	GS1
Package	10860004936876	GS1	Case	12	In Commercial Distribution