WAFFLE

Basic Information

• Brand Name: WAFFLE
• Primary DI: 10603354200545
• Version / Model: REV00
• Catalog Number: 2400WCXXCOV
• Company Name: EHOB INC
• Labeler DUNS: 150600252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-21
• Public Version: 1
• Public Version Date: 2020-08-31
• Public Version Status: New
• Public Device Record Key: c5c4fc9e-da58-46ca-a521-ecfecf14101b

Device Description

240WC WAFFLE EXTENDED CARE BARIATRIC CUSHION COVER - SNGL

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: 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: 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
KIC	Cushion, Flotation	Physical Medicine	890.3175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62720	Medical cushion cover	A device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603354200545	GS1