DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756686211
• Version / Model: HD-395-0700
• Catalog Number: HD-395-0700
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-23
• Public Version: 1
• Public Version Date: 2021-07-01
• Public Version Status: New
• Public Device Record Key: c6514c04-ec03-4dfe-8708-c6ca5df0d039

Device Description

EMESIS BASIN - 700CC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FNY	BASIN, EMESIS	General Hospital	880.6730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42871	Emesis bowl, single-use	A device designed as a receptacle for vomit or oral secretions, typically from an immobile patient (e.g., one confined to bed, chair, or wheelchair). It is typically shallow and kidney-shaped, and therefore commonly known as a kidney bowl or basin. It is typically made of disposable plastic materials, and is discarded with its waste contents. The device is also commonly used to hold and transport medical/surgical materials or instruments for a procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756686216	GS1	Case	320	In Commercial Distribution
Primary	00749756686211	GS1

Customer Contacts

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