Medegen Medical Products, LLC

Basic Information

• Brand Name: Medegen Medical Products, LLC
• Primary DI: 00700812001669
• Version / Model: H310-10
• Company Name: MEDEGEN MEDICAL PRODUCTS, LLC
• Labeler DUNS: 055527753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2020-12-20
• Public Version: 1
• Public Version Date: 2020-12-28
• Public Version Status: New
• Public Device Record Key: e557e870-0e24-45fc-a30a-d823aa98b890

Device Description

Basin Emesis 700cc Rose 250/cs 64/plt

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
FNY	BASIN, EMESIS	General Hospital	880.6730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11522	Emesis bowl, reusable	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 high-grade stainless steel or durable plastic materials, and is also commonly used to hold and transport medical/surgical materials or instruments for a procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00700812001669	GS1
Unit of Use	10700812001666	GS1