Ever-Soft Positioning Wedge

Basic Information

• Brand Name: Ever-Soft Positioning Wedge
• Primary DI: 00840117307728
• Version / Model: 13001
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-22
• Public Version: 1
• Public Version Date: 2021-04-30
• Public Version Status: New
• Public Device Record Key: f88d7f84-5897-4f71-9b0d-82ec3d52a2c6

Device Description

Positioning Wedge 8"x8"x24", 45 Degrees

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
IMP	Cushion, Wheelchair	Physical Medicine	890.3920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63407	Assistive sleeping cushion set	A collection of cushions, pads, pillows and bolsters intended to provide support and optimal positioning for a disabled person during sleep. The items are typically made of soft textile or synthetic materials and include pieces designed for specific body parts (e.g., head, shoulders, back, hips, knees, feet) used during different sleeping positions (supine, side, or prone lying). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00616784300146	GS1	Shipper	2	In Commercial Distribution
Primary	00840117307728	GS1