EZ WIDER, FOOT LENGTH EXTENSION

Basic Information

• Brand Name: EZ WIDER, FOOT LENGTH EXTENSION
• Primary DI: 00850520008129
• Version / Model: ASM100106
• Company Name: KREG MEDICAL INC.
• Labeler DUNS: 079220324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-12
• Public Version: 1
• Public Version Date: 2020-06-22
• Public Version Status: New
• Public Device Record Key: 37fddc0a-efa2-4e51-b328-277b23cb46f2

Device Description

Food Length Extension

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: Yes
• 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
KIC	Cushion, Flotation	Physical Medicine	890.3175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41058	Multifunction body cushion	A soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.	No	Active
30034	Bed extension	A device intended to be use to increase the length of a bed.	No	Active
11095	Foot cushion	A soft pillow or pad used to provide support and comfort to the user's feet, often during the treatment and/or prevention of musculoskeletal or circulatory disorders. The device may simply be used to alleviate pressure on the heels while the patient is sitting, or to slightly elevate the feet to reduce pressure and improve blood circulation in the lower extremity for the prevention of pressure sores and ulcers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850520008129	GS1

Customer Contacts

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